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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Teratoma; Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor

Treatments: Drug: sunitinib malate

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00453310

P30CA008748 (U.S. NIH Grant/Contract)

MSKCC-07004

07-004

Details and patient eligibility

About

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.

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

sunitinib malate

Experimental group

Description:

The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)

Treatment:

Drug: sunitinib malate