Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00453310 |
|
Recruitment Status :
Completed
First Posted : March 28, 2007
Results First Posted : October 27, 2015
Last Update Posted : October 27, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor | Drug: sunitinib malate | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors |
| Study Start Date : | March 2007 |
| Actual Primary Completion Date : | November 2008 |
| Actual Study Completion Date : | November 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: sunitinib malate
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 |
- Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment [ Time Frame: 2 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453310
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Dean F. Bajorin, MD | Memorial Sloan Kettering Cancer Center | |
| Principal Investigator: | Robert J. Motzer, MD | Memorial Sloan Kettering Cancer Center |
| Responsible Party: | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00453310 |
| Other Study ID Numbers: |
07-004 P30CA008748 ( U.S. NIH Grant/Contract ) MSKCC-07004 |
| First Posted: | March 28, 2007 Key Record Dates |
| Results First Posted: | October 27, 2015 |
| Last Update Posted: | October 27, 2015 |
| Last Verified: | September 2015 |
|
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 |
|
Neoplasms Neoplasms, Germ Cell and Embryonal Teratoma Testicular Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neoplasms by Histologic Type Genital Neoplasms, Male |
Testicular Diseases Sunitinib Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |