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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453310
• Other study ID #: 07-004
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: September 24, 2015
• Start date: March 2007
• Est. completion date: November 2008

Study information

• Verified date: September 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Teratoma
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• sunitinib malate

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

Feldman DR, Ginsberg MS, Turkula S, et al.: Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors (GCT). [Abstract] 2009 Genitourinary Cancers Symposium, Feb 26-28, 2009, Orlando, Florida. A-236, 2009.

Feldman DR, Turkula S, Ginsberg MS, Ishill N, Patil S, Carousso M, Bosl GJ, Motzer RJ. Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors. Invest New Drugs. 2010 Aug;28(4):523-8. doi: 10.1007/s10637-009-9280-2. Epub 2009 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment		2 years	No