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

NCT00453310 | Completed Phase 2 Results

• 3 other identifiers: 07-004P30CA008748MSKCC-07004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

recurrent ovarian germ cell tumor; stage IV ovarian germ cell tumor; ovarian choriocarcinoma; ovarian immature teratoma; ovarian mature teratoma; recurrent malignant testicular germ cell tumor; testicular choriocarcinoma; testicular seminoma; testicular yolk sac tumor; ovarian dysgerminoma; ovarian embryonal carcinoma; ovarian yolk sac tumor; ovarian monodermal and highly specialized teratoma; ovarian polyembryoma; stage III malignant testicular germ cell tumor; ovarian mixed germ cell tumor; testicular choriocarcinoma and embryonal carcinoma; testicular choriocarcinoma and seminoma; testicular choriocarcinoma and teratoma; testicular choriocarcinoma and yolk sac tumor; testicular embryonal carcinoma and seminoma; testicular embryonal carcinoma and teratoma with seminoma; testicular embryonal carcinoma and teratoma; testicular embryonal carcinoma and yolk sac tumor with seminoma; testicular embryonal carcinoma and yolk sac tumor; testicular yolk sac tumor and teratoma with seminoma; testicular yolk sac tumor and teratoma; testicular embryonal carcinoma; recurrent extragonadal non-seminomatous germ cell tumor; recurrent extragonadal seminoma; stage IV extragonadal non-seminomatous germ cell tumor; stage IV extragonadal seminoma; recurrent extragonadal germ cell tumor; testicular immature teratoma; testicular mature teratoma; adult teratoma

Outcome Measures

Primary Outcomes (1)

• Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment

  2 years

Study Arms (1)

sunitinib malate

EXPERIMENTAL

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)

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

sunitinib malate

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Pfizer: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• 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 Jun 23.

  PMID: 19547919 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Teratoma; Testicular Germ Cell Tumor; Testicular Neoplasms; Seminoma; Endodermal Sinus Tumor; Dysgerminoma; Carcinoma, Embryonal

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases; Germinoma; Mesonephroma

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Robert Motzer
• Organization: Memorial Sloan Kettering Cancer Center

motzerr@mskcc.org

646-422-4312

Study Officials

• Dean F. Bajorin, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Robert J. Motzer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 28, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 27, 2015
• Results First Posted: October 27, 2015

Record last verified: 2015-09

Locations

US (1)