Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:March 2005

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A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or CT-2103 Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

This randomized phase III trial studies paclitaxel to see how well it works compared to
polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV
ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy,
such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth
of tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel
and polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal
cancer by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not
need additional treatment until it progresses. In this case, observation may be sufficient.
It is not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or
observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.

PRIMARY OBJECTIVES:

I. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to
women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a
clinically-defined complete response to primary platinum/taxane-based chemotherapy
("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment
at the time of documented disease progression.

II. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity
profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic
Oncology Group [GOG] NTX4) and superior quality-of-life (as measured by the Functional
Assessment of Cancer Therapy-Ovarian [FACT-O]), compared to paclitaxel.

SECONDARY OBJECTIVES:

I. To explore the relationship between expression of several of the angiogenic markers and
overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel,
or no treatment.

II. To assess the association among the various tissue and serum markers of angiogenesis,
and compare the ability of different combinations of these markers to predict patient
outcome including overall survival and progression-free survival in patients randomized to
CT-2103, paclitaxel, or no treatment.

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 randomized to 1 of 3 treatment arms.

ARM I: Patients receive polyglutamate paclitaxel intravenously (IV) over 10-20 minutes on
day 1.

ARM II: Patients receive paclitaxel IV over 3 hours on day 1.

ARM III: Patients receive no further anticancer treatment until evidence of disease
progression.

In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 10 years.

Inclusion Criteria:

- Patients with a histologic diagnosis of primary peritoneal carcinoma, or stage III or
IV epithelial ovarian or fallopian tube carcinoma, with either optimal (=< 1 cm
residual disease) or suboptimal residual disease following initial surgery; all
patients must have had appropriate surgery for ovarian, primary peritoneal or
fallopian tube carcinoma with appropriate tissue available for histologic evaluation
to confirm diagnosis and stage

- 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 tumor

- Adenocarcinoma not otherwise specified (NOS)

- Patients must have completed treatment within the past 12 weeks with at least 5
cycles and not more than 8 cycles of a platinum (IV or intraperitoneal [IP]) and
paclitaxel or docetaxel-based combination chemotherapy and have no symptoms
suggestive of persistent cancer, normal (no evidence of cancer) computed tomography
(CT) scan of the abdomen/pelvis and normal cancer antigen 125 (CA-125) following this
therapy

- Patients treated with neo-adjuvant platinum-taxane chemotherapy for a
presumptive diagnosis of stage III or IV epithelial ovarian, primary peritoneal
or, fallopian tube (by paracentesis, percutaneous biopsy or open biopsy) are
eligible provided that they have undergone interval abdominal surgery after at
least one but no more than six cycles of standard chemotherapy; such surgery
must meet the same criteria as for those undergoing up front surgery, including
tissue diagnosis for confirmation of primary tumor site and stage III or IV
disease; also, patients must have received at least two cycles after interval
abdominal surgery

- Absolute neutrophil count >= 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE
version [v]3.0) grade 1

- Platelet count >= 100,000/ul

- Creatinine =< 1.5 times institutional upper limit of normal (ULN), CTCAE v3.0 grade 1

- Bilirubin =< 1.5 times ULN, (CTCAE v3.0 grade 1)

- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times ULN (CTCAE v3.0 grade 1)

- Alkaline phosphatase =< 2.5 times ULN (CTCAE v3.0 grade 1)

- Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1

- Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

- Patients must have signed an approved informed consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization

- Patients must complete pre-entry assessments

Exclusion Criteria:

- Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of
low malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with
a prior diagnosis of a low malignant potential tumor that was surgically resected and
who subsequently develop invasive adenocarcinoma are eligible, provided that they
have not received prior chemotherapy for their ovarian LMP tumor

- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or
carcinosarcomas, metastatic carcinomas from other sites to the ovary and low
malignant potential tumors including so called micropapillary serous carcinomas are
not eligible

- Patients who have received prior radiotherapy to any portion of the abdominal cavity
or pelvis are excluded; prior radiation for localized cancer of the breast, head and
neck, or skin is permitted, provided that it was completed more than 3 years prior to
registration, and the patient remains free of recurrent or metastatic disease

- Patients who have received investigational therapies, and/or biological therapies
(i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or
fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded;
however, biologics cannot be continued concurrent with the GOG-012 maintenance
treatment (or observation); patients who have received prior chemotherapy for any
other abdominal or pelvic tumor (except as noted above) are excluded; patients may
have received prior adjuvant chemotherapy for localized breast cancer, provided that
it was completed more than 3 years prior to registration, and that the patient
remains free of recurrent or metastatic disease

- 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

- Less than 3 mm invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions

- With the exception of non-melanoma skin cancer and other specific malignancies as
noted above, patients with other invasive malignancies 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 are excluded

- Patients with acute hepatitis, or known chronic hepatitis

- Patients with an active infection that requires antibiotics

- Patients with ongoing gastrointestinal bleeding requiring blood product support

- Patients whose circumstances at the time of entry onto the protocol would not permit
completion of study or required follow up

- Patients with unstable angina or those who have had a myocardial infarction within
the past six months; patients with evidence of abnormal cardiac conduction (e.g.
bundle branch block, heart block) are eligible if their disease has been stable for
the past six months

- Patients are excluded who have had prior therapy with CT-2103

- Patients with active bleeding or an unexplained prothrombin time (PT) or partial
thromboplastin time (PTT) > institutional upper limit normal (ULN)

- Patients who are pregnant or nursing are excluded; patients who may become pregnant
must practice an effective method of birth control
We found this trial at
314
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800 Washington St
Boston, Massachusetts 02111
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
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Fort Myers, Florida 33901
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
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301 University Blvd
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(409) 772-1011
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2500 N State St
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(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
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200 North Park Street
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529 West Markham Street
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8700 Beverly Blvd # 8211
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(1-800-233-2771)
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300 Community Drive
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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1 Gustave L Levy Pl # 271
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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4805 Northeast Glisan Street
Portland, Oregon 97213
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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401 College Street
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600 8th Street South
Saint Petersburg, Florida 33701
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Seattle, Washington 98104
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
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1100 Fairview Avenue North
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3900 W Avera Drive
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601 South Sherman Street
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1200 Old York Road
Abington, Pennsylvania 19001
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1 Akron General Ave
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Albany, New York 12208
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Albuquerque, New Mexico 87106
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
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5301 McAuley Drive
Ann Arbor, Michigan 48197
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Ann Arbor, Michigan 48106
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
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Asheville, North Carolina 28816
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13001 E. 17th Pl.
Aurora, Colorado 80045
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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Baton Rouge, Louisiana 70815
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Big Rapids, Michigan 49307
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
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Brightwaters, New York 11718
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Burlington, North Carolina 27216
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Burlington, Vermont 05405
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
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2600 Sixth St. SW
Canton, Ohio 44710
330.363.4908
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37403
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Chattanooga, Tennessee 37403
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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303 East Superior Street
Chicago, Illinois 60611
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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Clearwater, Florida 33756
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
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2049 E 100th St
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2500 Metrohealth Dr
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216-368-2000
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6001 E Woodmen Rd
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1 Hospital Dr
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1831 Fifth Avenue
Columbus, Georgia 31904
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Columbus, Ohio 43222
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3535 Olentangy River Rd
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4050 Coon Rapids Blvd NW
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100 North Academy Avenue
Danville, Pennsylvania 17822
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1 Wyoming St,
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Denver, Colorado 80210
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4567 E 9th Ave
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Denver, Colorado 80218
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1111 6th Ave
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(515) 247-3121
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700 E University Ave
Des Moines, Iowa 50316
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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4160 John R St #2122
Detroit, Michigan 48201
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