Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/9/2018
Start Date:December 6, 2007

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A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865)

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride
when given together with or without bevacizumab after surgery to see how well it works in
treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that
has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine
hydrochloride work in different ways to stop the growth of tumor cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal
antibodies, such as bevacizumab, may block tumor growth in different ways by targeting
certain cells. It is not yet known whether combination chemotherapy is more effective when
given with or without bevacizumab after surgery in treating patients with ovarian,
epithelial, primary peritoneal, or fallopian tube cancer.

PRIMARY OBJECTIVES:

I. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy
increases the duration of overall survival in patients with recurrent platinum sensitive
epithelial ovarian cancer, peritoneal primary or fallopian tube cancer.

II. To determine if the addition of bevacizumab to the second-line and maintenance phases of
treatment increases the duration of overall survival relative to second-line paclitaxel and
carboplatin alone in patients with recurrent platinum sensitive epithelial ovarian cancer,
peritoneal primary or fallopian tube cancer.

SECONDARY OBJECTIVES:

I. To determine if the addition of bevacizumab to the second-line and maintenance phase of
treatment increases the duration of progression-free survival relative to second-line
paclitaxel and carboplatin alone in patients with recurrent platinum sensitive epithelial
ovarian cancer, peritoneal primary or fallopian tube cancer.

II. To prospectively determine the incidence of carboplatin and paclitaxel hypersensitivity
in these patients undergoing retreatment with both agents as first recurrence therapy.

III. To determine if surgical secondary cytoreduction in addition to adjuvant chemotherapy
increases quality of life (QOL) in patients with recurrent platinum-sensitive epithelial
ovarian cancer, peritoneal primary or fallopian tube cancer, as measured by the Functional
Assessment of Cancer Therapy-Ovarian (FACT-O) trial outcome index and Rand Short Form (SF)-36
physical functioning scale.

IV. To determine if the addition of bevacizumab to the second-line and maintenance phases of
treatment increases QOL relative to second-line paclitaxel and carboplatin alone in patients
with recurrent platinum-sensitive epithelial ovarian, peritoneal primary or fallopian tube
cancer.

TERTIARY OBJECTIVES:

I. To define molecular and biochemical profiles associated with the duration of
progression-free survival in platinum-sensitive recurrent ovarian, peritoneal primary or
fallopian tube carcinoma treated with combination chemotherapy with or without bevacizumab
followed with or without maintenance bevacizumab therapy in the presence or absence of
secondary surgical cytoreduction.

II. To identify molecular determinants that predict sensitivity or resistance to carboplatin
and paclitaxel with or without bevacizumab followed with or without maintenance bevacizumab
therapy.

III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the
association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome
including overall survival, progression-free survival and adverse events.

OUTLINE: Patients are assigned to 1 of 4 treatment groups. Patients who are not candidates
for surgical cytoreduction (i.e., those for whom complete cytoreduction in the estimation of
the investigator is impossible or a medical infirmity precludes exploration and debulking)
are eligible to receive chemotherapy after randomization.

Patients who are eligible for surgery undergo abdominal exploration with cytoreduction.
Patients are then randomized to 1 of 4 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours or docetaxel IV over 1
hour and carboplatin IV over 60 minutes on day 1.

ARM II: Patients receive chemotherapy as in Arm I and bevacizumab IV over 30-90 minutes on
day 1.

ARM III: Patients receive gemcitabine hydrochloride IV over 60 minutes on days 1 and 8 and
carboplatin as in Arm I.

ARM IV: Patients receive gemcitabine hydrochloride IV as in Arm III, bevacizumab IV and
carboplatin IV as in Arm II.

In all arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

Patients with measurable disease achieving a clinical response (CR) receive 6-8 courses of
therapy. Patients with stable disease or partial regression receive a maximum of 8 courses.

Patients without measurable lesions as determined by a computed tomography (CT) scan prior to
initiating study treatment continue therapy for 6 courses or, if cancer antigen (CA)-125
normalizes, for 2 courses beyond CA-125 normalization, whichever is greater. Patients in Arm
II then receive a maintenance regimen comprising bevacizumab IV over 30-90 minutes. Treatment
with bevacizumab alone repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then yearly for 5 years.

Inclusion Criteria:

- Patients enrolled after August 28, 2011 must be candidates for cytoreductive surgery
and consent to have their surgical treatment determined by randomization

- Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal
primary or fallopian tube carcinoma, which is now recurrent

- Patients with the following histologic epithelial cell types are eligible: serous
adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell
carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified
(N.O.S.)

- Patients must have had a complete response to front-line platinum-taxane therapy (at
least three cycles)

- A complete response to front-line chemotherapy must include: negative physical exam,
negative pelvic exam and normalization of CA125, if elevated at baseline; although not
required, any radiographic assessment of disease status (e.g. CT, magnetic resonance
imaging [MRI], positron emission tomography [PET]/CT, etc) obtained following the
completion of primary therapy should be considered negative for disease

- All patients must have also had a treatment-free interval without clinical evidence of
progressive disease of at least 6 months from completion of front-line chemotherapy
(both platinum and taxane); front-line therapy may have included a biologic agent
(i.e. bevacizumab)

- Front-line treatment may include maintenance therapy following complete clinical or
pathological response; however, maintenance cytotoxic chemotherapy must be
discontinued for a minimum of 6 months prior to documentation of recurrent disease;
patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE
provided their recurrence is documented more than 6 months from primary cytotoxic
chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has
elapsed since their last infusion of biological therapy

- Patients must have clinically evident recurrent disease for the purpose of this study

- Measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]) is defined
as at least one lesion that can be accurately measured in at least one dimension
(longest dimension to be recorded); each lesion must be more than or equal to 20 mm
when measured by conventional techniques, MRI or CT, or more than or equal to 10 mm
when measured by spiral CT

- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to
Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1

- Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)

- Creatinine (non-isotope dilution mass spectrometry [IDMS]) =< 1.5 x institutional
upper limit normal (ULN), CTCAE grade 1

- Total bilirubin =< 1.5 ULN (CTCAE grade 1)

- Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) =< 2.5
times the upper limit of normal in the absence of liver metastasis; SGOT/AST < 5.0
times ULN in the presence of liver metastasis

- Alkaline phosphatase =< 2.5 times the upper limit of normal in the absence of liver
metastasis; alkaline phosphatase < 5.0 times ULN in the presence of liver metastasis

- This criterion applies only to the patients enrolled before August 29, 2011 and those
enrolled after this date electing to receive bevacizumab; patients must have a urine
protein-to-creatinine ratio (UPCR) < 1.0 mg/dL

- This eligibility criterion does not apply to patients enrolled after August 28, 2011;
patients who are not candidates for surgical cytoreduction are eligible for the
chemotherapy randomization; patients are not considered candidates for surgical
cytoreduction if complete cytoreduction in the estimation of the investigator is
impossible or a medical infirmity precludes exploration and debulking

- Patients must have met the pre-entry requirements as specified

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

Exclusion Criteria:

- Patients who have received more than one previous regimen of chemotherapy (maintenance
is not considered a second regimen)

- Patients receiving concurrent immunotherapy, or radiotherapy

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded

- Patients whom have already undergone secondary cytoreduction for recurrent disease are
excluded

- Patients with a prior histologic diagnosis of borderline, low malignant potential
(grade 0) epithelial carcinoma that was surgically resected and who subsequently
developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer
are eligible provided that they meet the criteria listed above

- Patients who require parenteral hydration or nutrition and have evidence of partial
bowel obstruction or perforation

- Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other
than ovarian, fallopian tube, and primary peritoneal) are excluded

- Patients with synchronous primary endometrial cancer, or a past history of primary
endometrial cancer, are excluded, unless all of the following conditions are met:
stage not greater than I-B; no more than superficial myometrial invasion, without
vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary
serous, clear cell or other International Federation of Gynecology and Obstetrics
(FIGO) grade 3 lesions

- Patients with uncontrolled infection

- Patients with concurrent severe medical problems unrelated to the malignancy that
would significantly limit full compliance with the study or expose the patient to
extreme risk or decreased life expectancy

- Patients with >= grade 2 peripheral neuropathy

- Patients with a history of allergic reactions to carboplatin and/or paclitaxel or
chemically similar compounds; patients with allergic (hypersensitivity) reactions to
these chemotherapeutic agents are NOT excluded IF they were successfully retreated
following a desensitization program or protocol

- This criterion applies only to the patients enrolled before August 29, 2011 and those
enrolled after this date electing to receive bevacizumab; patients with known
hypersensitivity to Chinese hamster ovary cell products or other recombinant human or
humanized antibodies

- Patients of childbearing potential, not practicing adequate contraception, patients
who are pregnant or patients who are nursing are not eligible for this trial;
bevacizumab should not be administered to nursing women

- Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer, who had (or have) any evidence of the other cancer present within the last 5
years or whose previous cancer treatment contraindicates this protocol therapy

- This criterion applies only to the patients enrolled before August 29, 2011 and those
enrolled after this date electing to receive bevacizumab; patients with active
bleeding or pathologic conditions that carry high risk of bleeding such as a known
bleeding disorder, coagulopathy, or tumor involving major vessels

- This criterion applies only to the patients enrolled before August 29, 2011 and those
enrolled after this date electing to receive bevacizumab; patients with a history or
evidence upon physical examination of central nervous system (CNS) disease, including
primary brain tumor, seizures not controlled with standard medical therapy, any brain
metastases or a history of stroke within 5 years of the first date of treatment on
this study

- This criterion applies only to the patients enrolled before August 29, 2011 and those
enrolled after this date electing to receive bevacizumab; patients with clinically
significant cardiovascular disease; this includes:

- Patients with significant cardiac conduction abnormalities, i.e. PR interval >
0.24 seconds (sec) or 2nd or 3rd degree atrioventricular (AV) block

- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm
Hg

- Myocardial infarction, cardiac arrhythmia or unstable angina < 6 months prior to
registration

- New York Heart Association (NYHA) grade II or greater congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Grade II or greater peripheral vascular disease (exception: episodes of ischemia
< 24 hours [hrs] in duration, that are managed non-surgically and without
permanent deficit)

- History of cerebrovascular attack (CVA) within six months

- This criterion applies only to the patients enrolled before August 29, 2011 and those
enrolled after this date electing to receive bevacizumab; patients who have had a
major surgical procedure, open biopsy, dental extractions or other dental
surgery/procedure that results in an open wound, or significant traumatic injury
within 28 days prior to the first date of treatment on this study, or anticipation of
need for major surgical procedure during the course of the study; patients with
placement of vascular access device or core biopsy within 7 days prior to the first
date of treatment on this study

- Patients undergoing pre-treatment secondary cytoreduction will undergo therapy with
bevacizumab on cycle #2

- Patients undergoing pre-treatment surgery for purposes other than cytoreduction may
also participate provided they meet eligibility; patients randomized to arms
containing bevacizumab must wait a minimum of 28 days since that procedure to begin
protocol treatment; patients who undergo an uncomplicated port placement must wait a
minimum of 7 days to begin protocol treatment
We found this trial at
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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1500 East Medical Center Drive
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Bellevue, Washington 98005
Principal Investigator: Keith S. Lanier
Phone: 503-215-6412
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Bellevue, WA
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Bellingham, Washington 98226
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Bellingham, WA
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Bellingham, Washington 98225
Principal Investigator: Benjamin B. Bridges
Phone: 208-381-3376
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Bellingham, WA
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 614-488-2745
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Belpre, OH
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Principal Investigator: Maria C. Bell
Phone: 605-328-1368
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Bemidji, MN
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Bend, Oregon 97701
Principal Investigator: Benjamin B. Bridges
Phone: 208-381-3376
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Bend, OR
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Berkeley, CA
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Berlin, VT
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: William J. Lowery
Phone: 301-319-2100
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Bethesda, MD
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Bethlehem, Pennsylvania 18015
Principal Investigator: Nicholas P. Taylor
Phone: 610-954-3582
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Bethlehem, PA
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Big Rapids, Michigan 49307
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Big Rapids, MI
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Maria C. Bell
Phone: 605-328-1368
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Bismarck, ND
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Bloomington, IL
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Bloomington, Illinois 61701
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Bloomington, IL
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Benjamin B. Bridges
Phone: 208-381-3376
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, ID
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Boise, Idaho 83706
Principal Investigator: J. R. Liu
Phone: 734-712-3456
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Boise, ID
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Bolivar, Missouri 65613
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Bolivar, MO
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Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Bonne Terre, MO
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, CO
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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Boulder, CO
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Branson, Missouri 65616
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Branson, MO
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Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 800-998-2119
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Bremerton, WA
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Bridgeport, Connecticut 06606
Principal Investigator: Paul E. Berard
Phone: 203-576-6329
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Bridgeport, CT
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 734-712-3456
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Brighton, MI
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: J. R. Liu
Phone: 734-712-3456
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Brighton, MI
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Brightwaters, New York 11718
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Brightwaters, NY
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Bristol, Tennessee 37620
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bristol, TN
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Bristol, Tennessee 37620
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bristol, TN
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Bristol, Virginia 24201
Principal Investigator: Asheesh Shipstone
Phone: 423-578-8538
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Bristol, VA
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Brooklyn, New York 11203
Principal Investigator: Ovadia Abulafia
Phone: 718-613-8324
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Brooklyn, NY
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263 7th Avenue
Brooklyn, New York 11215
Principal Investigator: Katherine Economos
Phone: 718-780-3677
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Brooklyn, NY
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