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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00453310
• Collaborator: National Cancer Institute (NCI) (NIH), Pfizer (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 20.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor	Drug: sunitinib malate	Phase 2

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.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2007
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Dean F. Bajorin, MD, Memorial Sloan Kettering Cancer Center
• Principal Investigator: Robert J. Motzer, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00453310
• Other Study ID Numbers: 07-004; P30CA008748; MSKCC-07004
• First Posted: Mar 28, 2007
• Last Update Posted: Oct 27, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Memorial Sloan Kettering Cancer Center: 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
• Additional relevant MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Teratoma; Testicular Neoplasms; Sunitinib

Study Results

Participant Flow

Arm/Group Title	Sunitinib Malate
Arm/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) sunitinib malate
Period Title: Overall Study
STARTED	10
COMPLETED	0
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Sunitinib Malate
Arm/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) sunitinib malate
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%

Outcome Measures

1. Primary Outcome

Title	Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sunitinib Malate
Arm/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) sunitinib malate
Measure Participants	10
Stable Disease	3 30%
Progression of Disease	7 70%

Adverse Events

Arm/Group Title	Sunitinib Malate
Arm/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) sunitinib malate
All Cause Mortality
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	1/10 (10%)
Gastrointestinal disorders
Hemorrhage, Abdomen NOS	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Sunitinib Malate
	Affected / at Risk (%)	# Events
Total	8/10 (80%)
Blood and lymphatic system disorders
ALT, SGPT	2/10 (20%)	2
Glucose, high (hyperglycemia)	1/10 (10%)	1
Leukocytes (total WBC)	4/10 (40%)	4
Lymphopenia	2/10 (20%)	2
Cardiac disorders
Hypertension	1/10 (10%)	1
General disorders
Hemorrhage, Nose	1/10 (10%)	1
Mucositis (func/sympt)- Oral cavity	2/10 (20%)	2
Pain - Extremity-limb	1/10 (10%)	1
Nervous system disorders
Neuropathy: motor	1/10 (10%)	1
Neuropathy: sensory	1/10 (10%)	1
Renal and urinary disorders
Urinary frequency/urgency	1/10 (10%)	1
Skin and subcutaneous tissue disorders
Rash/desquamation	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.