Clinical trial NCT00453310: Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Official title: A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Pfizer
First posted: 2007-03-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dean F. Bajorin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Robert J. Motzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.