Ovarian Cancer Clinical Trial

Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.

View Full Description

Full Description

OBJECTIVES:

Primary

Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.

Secondary

Determine the safety of this drug in these patients.
Determine the time to tumor response and duration of tumor response in patients treated with this drug.

OUTLINE: This is a open-label study.

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 28 days and then periodically thereafter.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed seminoma or nonseminoma germ cell tumors (GCT)

Refractory or relapsed disease
Metastatic disease

Progressive disease after prior cisplatin-based chemotherapy AND meets 1 of the following criteria for salvage therapy:

Not a candidate for potentially curative therapy
Received prior high-dose chemotherapy regimens
Declines potentially curative therapy (mediastinal GCT or primary refractory GCT)

Measurable disease*, defined as 1 of the following:

At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Elevation of alpha-fetoprotein > 15 ng/mL and/or elevation of human chorionic gonadotropin > 2.2 mIU/L
NOTE: *Patients with radiographically measurable disease only must have ≥ 1 site that has not undergone prior irradiation

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9.0 g/dL
Creatinine ≤ 1.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
AST and ALT ≤ 2.5 times ULN (unless elevated liver function abnormalities due to underlying malignancy)
LVEF ≥ 50% by MUGA
No grade 3 hemorrhage within the past 4 weeks

None of the following within the past 6 months:

Myocardial infarction
Severe or unstable angina
Coronary or peripheral artery bypass graft
Symptomatic congestive heart failure
Cerebrovascular accident or transient ischemic attack
Pulmonary embolism
No prolonged QTc interval (i.e., QTc > 450 msec for males and > 470 msec for females)
No ongoing cardiac dysrhythmias ≥ grade 2
No uncontrolled hypertension, defined as blood pressure > 150/100 mm Hg despite optimal therapy
No active infection
No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance, according to the study investigator

Not pregnant or nursing

Negative sonogram required to exclude pregnancy
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior sunitinib malate
More than 4 weeks since prior major surgery and recovered
More than 4 weeks since prior radiotherapy and recovered
Concurrent palliative radiotherapy to metastatic lesion(s) allowed provided ≥ 1 measurable lesion has not been irradiated

No concurrent therapeutic doses of warfarin

Low-dose oral warfarin (up to 2 mg daily) for prophylaxis and treatment or heparin products at prophylactic or treatment doses allowed

No other concurrent investigational or approved anticancer therapies, including chemotherapy, biologic response modifiers, hormone therapy, or immunologic-based treatment

Concurrent participation in supportive care or nontreatment trials (e.g., quality-of-life or laboratory analyses) allowed

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00453310

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

10

Study ID:

NCT00453310

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider