Carboplatin and Paclitaxel With or Without Ramucirumab in Treating Patients With Locally Advanced, Recurrent, or Metastatic Thymic Cancer That Cannot Be Removed by Surgery



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:August 9, 2018
End Date:June 1, 2023

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A Randomized Phase II Trial of Carboplatin-Paclitaxel With or Without Ramucirumab in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma

This randomized phase II trial studies how well carboplatin and paclitaxel with or without
ramucirumab work in treating patients with thymic cancer that has spread to other places in
the body, has come back, or cannot be removed by surgery. Drugs used in chemotherapy, such as
carboplatin and paclitaxel, 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 ramucirumab, may interfere with the ability of tumor cells to
grow and spread. It is not yet known if giving carboplatin and paclitaxel with or without
ramucirumab will work better in treating patients with thymic cancer.

PRIMARY OBJECTIVES:

I. To compare progression-free survival between patients with incurable unresectable locally
advanced, or recurrent, or metastatic thymic carcinoma randomized to carboplatin-paclitaxel
with or without ramucirumab.

SECONDARY OBJECTIVES:

I. To evaluate the frequency and severity of toxicity of carboplatin-paclitaxel with or
without ramucirumab in this patient population.

II. To compare the response rate (complete response, partial response, confirmed and
unconfirmed) between treatment arms.

III. To compare disease control rate (complete response, partial response, confirmed or
unconfirmed, stable disease) between treatment arms.

IV. To compare overall survival between treatment arms.

TERTIARY OBJECTIVES:

I. To bank specimens for future research.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive ramucirumab intravenously (IV) over 60 minutes, carboplatin IV, and
paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity. Patients who have not progressed may continue
to receive ramucirumab for up to 1 year.

ARM B: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, and
then every 6 months for 1 year.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed thymic carcinoma

- Patients must have unresectable thymic carcinoma that is either locally advanced,
recurrent, or metastatic

- Patients must not be candidates for localized surgery

- Patients must have measurable disease documented by computed tomography (CT) or
magnetic resonance imaging (MRI) within 28 calendar days prior to randomization; the
CT from a combined positron emission tomography (PET)/CT may be used only if it is of
diagnostic quality; non-measurable disease must be assessed within 42 calendar days
prior to randomization; all known sites of disease must be assessed and documented on
the baseline tumor assessment form (Response Evaluation Criteria in Solid Tumors
[RECIST] 1.1)

- Patients must have a Zubrod performance status of 0 to 2

- Patients must not have undergone major surgery within 28 calendar days prior to
randomization, or minor surgery/subcutaneous venous access device placement within 7
calendar days prior to randomization; the patient must not have elective or planned
major surgery to be performed during the course of the clinical trial

- Patients must not have had prior systemic anti-cancer therapy for locally advanced or
metastatic unresectable thymic carcinoma

- If patients have recurrent unresectable thymic carcinoma, patients may have had prior
neoadjuvant or adjuvant chemotherapy if treatment concluded >= 6 months prior to
randomization

- Patients must have a CT or MRI scan of the brain to evaluate for central nervous
system (CNS) disease within 42 calendar days prior to registration; patient must not
have brain metastases unless: (1) metastases have been treated and have remained
controlled for at least two weeks following treatment, AND (2) patient has no residual
neurological dysfunction off corticosteroids for at least 1 day

- Patients must not be candidates for radiation therapy with curative intent; prior
palliative radiation therapy is allowed as long as a period of 7 days has passed since
the last dose was received and the patient has recovered from any associated toxicity
at the time of randomization

- Absolute neutrophil count (ANC) >= 1500/mcL documented within 28 calendar days prior
to randomization

- Hemoglobin >= 9 g/dL (5.58 mmol/L) documented within 28 calendar days prior to
randomization

- Platelets >= 100,000/mcL documented within 28 calendar days prior to randomization

- International normalized ratio (INR) =< 1.5 documented within 28 calendar days prior
to randomization

- Partial thromboplastin time (PTT) =< 5 seconds above the institutional upper limit of
normal (IULN) (unless receiving anticoagulation therapy) documented within 28 calendar
days prior to randomization

- Patients receiving warfarin must be switched to low molecular weight heparin and have
achieved stable coagulation profile 14 days prior to randomization

- Patients must not have experienced any grade 3 or above gastrointestinal (GI) bleeding
within 84 calendar days prior to randomization

- Patients must not have a history of deep vein thrombosis (DVT), pulmonary embolism
(PE), or any other significant thromboembolism (venous port or catheter thrombosis or
superficial venous thrombosis are not considered ?significant?) during the 84 calendar
days prior to randomization

- Total bilirubin =< 1.5 x the institutional upper limit normal (IULN) documented within
28 calendar days prior to randomization

- Aspartate aminotransferase (aspartate transaminase [AST]) and alanine aminotransferase
(alanine transaminase [ALT]) =< 3.0 x IULN; for patients with liver metastases, total
bilirubin and AST or ALT must be =< 5.0 x IULN documented within 28 calendar days
prior to randomization

- Patients must not have any of following:

- Cirrhosis at a level of Child-Pugh B (or worse)

- Cirrhosis (any degree) and a history of hepatic encephalopathy; or

- Clinically meaningful ascites resulting from cirrhosis; clinically meaningful
ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis

- Serum creatinine =< 1.5 x IULN, or creatinine clearance (measured via 24-hour urine
collection) >= 40 mL/minute (that is, if serum creatinine is > 1.5 x ULN, a 24-hour
urine collection to calculate creatinine clearance must be performed) documented
within 28 calendar days prior to randomization

- Patient urinary protein must be =< 1+ on dipstick or routine urinalysis (UA); if urine
dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must
demonstrate < 1000 mg of protein in 24 hours); these tests must be documented within
28 calendar days prior to randomization

- Patients must not have experienced any arterial thromboembolic events, including but
not limited to myocardial infarction, transient ischemic attack, cerebrovascular
accident, or unstable angina, within 6 months prior to randomization

- Patients must not have a history of uncontrolled or poorly-controlled hypertension
(defined as > 160 mmHg systolic or > 100 mmHg diastolic for > 4 weeks) despite
standard medical management

- Patients must not be pregnant or nursing; women/men of reproductive potential must
have agreed to use an effective contraceptive method (hormonal or barrier method of
birth control; abstinence) prior to randomization, during the study participation and
for 4 months after the last dose of protocol treatment; a woman is considered to be of
"reproductive potential" if she has had menses at any time in the preceding 12
consecutive months; in addition to routine contraceptive methods, "effective
contraception" also includes heterosexual celibacy and surgery intended to prevent
pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy,
bilateral oophorectomy or bilateral tubal ligation; however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he/she is
responsible for beginning contraceptive measures

- Patients must not have experienced hemoptysis (defined as bright red blood or >= 1/2
teaspoon) within 2 months prior to randomization or with radiographic evidence of
intratumor cavitation or has radiologically documented evidence of major blood vessel
invasion or encasement by cancer

- Patients must not have a prior history of gastrointestinal perforation/fistula (within
6 months of randomization) or risk factors for perforation

- Patients must not have a serious or nonhealing wound, ulcer, or bone fracture within
28 calendar days prior to randomization

- Patients must not be receiving chronic antiplatelet therapy, including aspirin,
nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and
others), dipyridamole or clopidogrel, or similar agents within 7 days prior to
randomization; once-daily aspirin use (maximum dose 325 mg/day) is permitted

- Patients must be offered the opportunity to participate in banking of specimens for
future research

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system
We found this trial at
24
sites
640 Jackson Street
Saint Paul, Minnesota 55101
651-254-3456
Principal Investigator: David M. King
Phone: 952-993-1517
Regions Hospital Established in 1872, Regions Hospital is a private, not-for-profit organization. The hospital provides...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: John C. Ruckdeschel
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Burnsville, MN
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Principal Investigator: David M. King
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Edina, MN
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Principal Investigator: David M. King
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Maple Grove, Minnesota 55369
Principal Investigator: David M. King
Phone: 952-993-1517
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Maplewood, Minnesota 55109
Principal Investigator: David M. King
Phone: 952-993-1517
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1575 Beam Ave
Maplewood, Minnesota 55109
(651) 232-7000
Principal Investigator: David M. King
Phone: 888-823-5923
Saint John's Hospital - Healtheast St. John's Hospital is committed to providing superior health care...
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Maplewood, MN
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Minneapolis, Minnesota 55414
Principal Investigator: David M. King
Phone: 952-993-1517
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Minneapolis, Minnesota 55454
Principal Investigator: David M. King
Phone: 952-993-1517
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Principal Investigator: David M. King
Phone: 952-993-1517
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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501 Hospital Rd
New Richmond, Wisconsin 54017
(715) 243-2800
Principal Investigator: David M. King
Phone: 952-993-1517
Cancer Center of Western Wisconsin For community members who need effective and compassionate cancer care,...
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1324 5th St N
New Ulm, Minnesota 56073
(507) 217-5000
Principal Investigator: David M. King
Phone: 952-993-1517
New Ulm Medical Center New Ulm Medical Center is a nonprofit hospital and clinic serving...
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Portland, Oregon 97239
Principal Investigator: Anne S. Tsao
Phone: 713-792-6363
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3300 Oakdale Ave. N.
Robbinsdale, Minnesota 55422
763-520-5200
Principal Investigator: David M. King
Phone: 952-993-1517
North Memorial Medical Health Center North Memorial Health Care is a comprehensive health care system...
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3850 Park Nicollet Blvd
Saint Louis Park, Minnesota 55416
(952) 993-3123
Principal Investigator: David M. King
Phone: 952-993-1517
Park Nicollet Clinic - Saint Louis Park Park Nicollet Health Services is a nonprofit, integrated...
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333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
Principal Investigator: David M. King
Phone: 952-993-1517
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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1455 St Francis Ave
Shakopee, Minnesota 55379
(952) 428-3000
Principal Investigator: David M. King
Phone: 952-993-1517
Saint Francis Regional Medical Center St. Francis Regional Medical Center has a rich tradition of...
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630 Medical Dr
Stillwater, Minnesota 84010
(801) 299-2200
Principal Investigator: David M. King
Phone: 952-993-1517
Lakeview Hospital At Lakeview Hospital, our Mission is to provide the quality of healthcare we...
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500 S Maple Street
Waconia, Minnesota 55387
952-442-2191
Principal Investigator: David M. King
Phone: 952-993-1517
Ridgeview Medical Center Ridgeview Medical Center is an independent, nonprofit, regional health care system located...
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301 Becker Ave SW
Willmar, Minnesota 56201
(320) 235-4543
Principal Investigator: David M. King
Phone: 952-993-1517
Rice Memorial Hospital Rice Memorial Hospital is a Level 3 Trauma Center and the largest...
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Woodbury, Minnesota 55125
Principal Investigator: David M. King
Phone: 952-993-1517
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Wyoming, Minnesota 55092
Principal Investigator: David M. King
Phone: 952-993-1517
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