Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Oxaliplatin

Criteria

Inclusion Criteria:

• Patients must have histological or serologic proof of metastatic germ cell neoplasm (gonadal or extragonadal primary). Patients with seminoma and non-seminoma are eligible, as are women with ovarian germ cell tumors.

• Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of the investigator.

• Patients must have failed initial cisplatin combination chemotherapy administered with curative intent such as BEP, EP, VIP, or similar regimens.

• Patients should have failed and demonstrated progressive disease with high dose chemotherapy such as carboplatin and etoposide. (With the exception of late relapse or primary mediastinal non-seminomatous germ cell tumor.

• Patients with late relapse or primary mediastinal non-seminomatous germ cell tumors must have failed at least 1 salvage chemotherapy regimen.

• Patients must have had prior exposure to paclitaxel, gemcitabine, or the combination of paclitaxel + gemcitabine.

• Patients must have adequate hematologic function (WBC > 4,000/mm3 and platelets > 100,000/mm3) obtained < 4 weeks prior to registration.

• Patients must have adequate hepatocellular function (SGOT < 4 x normal and Bilirubin <2.0 mg/dl) obtained < 4 weeks from protocol registration.

• Serum Creatinine must be < 2.0 mg/dl obtained < 4 weeks from protocol registration.

• Patients must have an ECOG performance status of 0, 1, or 2.

• Patients must be at least 28 days post major surgery, open biopsy, or significant traumatic injury at time of study registration.

• Patients must be at least 7 days post any minor surgical procedure, excluding placement of a vascular access device at the time of study registration.

• Patients must be at least 18 years old at time of consent.

Exclusion Criteria:

• Patients who have an active, unresolved infection and/or are receiving concurrent treatment with parenteral antibiotics are ineligible. Patients are eligible after antibiotics have been discontinued for at least 7 days.

• Patients may not have any significant bleeding.

• Patients with INR > 1.5 are not eligible unless the patient is on anti-coagulants with a therapeutic INR between 1.5 and 3. Patients on coumadin are not eligible unless they are on low dose coumadin to keep a vascular access device patent.

• Patients with a history of arterial thromboses, unstable angina, transient ischemic attach (TIA), cerebral vascular accident (CVA), or a myocardial infarction within the last 6 months are not eligible.

• Patients must not have known CNS metastases. A Head CT or MRI will be performed only if clinically indicated.

• Patients must not have received any radiotherapy or chemotherapy within 28 days prior to study registration, and have recovered from all toxicity from prior treatments.

• Patients must not have any prior history of hypertensive crisis or hypertensive encephalopathy.

• Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure.

• Patients must not have history of significant vascular disease.

• Patients must not have evidence of bleeding diathesis or coagulopathy.

• Patients must not have inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).

• Patients must not have history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study registration.

• Patients must not have serious, non-healing would, ulcer or bone fracture.

• Patients must not have proteinuria at screening as demonstrated by a urine protein:

Creatinine (UPC) ratio of ≥ 1.0.

• Patients must not have a known sensitivity to any component of bevacizumab.

• Patients must not be pregnant or lactating.

• Patients must not have grade 3 or 4 neuropathy.

• Females of child bearing potential must not be pregnant. A negative pregnancy test is required within 7 days prior to beginning treatment.

NOTE THE FOLLOWING GUIDELINES FOR USE IN THIS PROTOCOL:

• Progressive metastatic disease will be documented by the appearance of metastatic lesions on PA and lateral chest x-ray, C.T. scan, or other imaging studies, or the presence of a rising serum HCG or AFP.

• If a rising serum marker is the only evidence of progressive disease, at least 2 consecutive determinations must be done exhibiting serologic progression and alternative causes for increased serum levels of these substances must not be present [cross reaction with LH (tested if necessary by testosterone suppression of LH), ingestion of marijuana, hepatitis, etc.].

• Patients will be considered to have failed a prior regimen if they fail to obtain a complete response per RECIST as outlined in section 6.

• Patients with clinical situation of growing teratoma (normal or declining markers and radiographic or clinical progression) should be considered for surgery.