Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors

Completed · Phase 2

Conditions studied: Recurrent Extragonadal Seminoma, Recurrent Malignant Extragonadal Germ Cell Tumor, Recurrent Malignant Extragonadal Non-Seminomatous Germ Cell Tumor, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Stage III Testicular Cancer, Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Ovarian Germ Cell Tumor

In brief

This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.

Key facts

Study ID

NCT00957905

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2009-06-01

Expected to finish

2014-08-01

Last updated by the study team

2017-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed germ cell tumor (GCT)
• Seminoma or non-seminoma
• Progressive disease after prior cisplatin-based therapy AND meets 1 of the following criteria:
• Not considered to be a candidate for potentially curative therapy
• Previously treated with high-dose chemotherapy regimens
• Does not wish to undergo potentially curative high-dose therapy
• Measurable or evaluable disease, as defined by 1 of the following criteria:
• Unidimensionally measurable metastatic disease, defined as ≥ 1 malignant tumor mass that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional CT scan or MRI or as ≥ 10 mm by spiral CT scan
• Bone lesions, ascites, peritoneal carcinomatosis, miliary lesions, pleural or pericardial effusions, lymphangitis of the skin or lung, cystic lesions, or irradiated lesions are not considered measurable disease
• Patients with measurable disease only (i.e., normal tumor markers) must have ≥ 1 site of disease that has not been previously irradiated
• Elevation of alpha-fetoprotein > 15 ng/mL and/or elevation of beta-human chorionic gonadotropin > 2.2 mIU/L
• If tumor markers are not elevated, ≥ 1 site of measurable disease must be present
• No known untreated CNS metastasis or primary CNS tumor
• Patients who have undergone local treatment for brain metastases and whose brain metastases are demonstrated to be stable by repeat imaging studies performed ≥ 4 weeks after treatment are eligible
• Karnofsky performance status 70-100%
• ANC ≥ 1,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 8.0 g/dL
• Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
• Total serum bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN (unless elevation is due to underlying malignancy)
• Not pregnant or nursing
• Negative pregnancy test by ultrasound
• Fertile patients must use effective contraception
• Willing and able to comply with scheduled study visits, treatment plans, laboratory tests, follow-up tests for safety or effectiveness, and other study procedures

Where it is running

• Tower Cancer Research Foundation — Beverly Hills, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• UPMC-Presbyterian Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States
• Riverview Hospital — Wisconsin Rapids, Wisconsin, United States

Full record on ClinicalTrials.gov

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