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


Phase 2
18 Years
N/A
Not Enrolling
Both
Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Confirmed objective response rate (complete and partial response) as measured by RECIST criteria after 2 courses of treatment

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Dean F. Bajorin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-004

NCT ID:

NCT00453310

Start Date:

March 2007

Completion Date:

November 2008

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021