Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients

Completed · Phase 2

Conditions studied: Neoplasms, Germ Cell and Embryonal

In brief

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

Key facts

Study ID

NCT00393861

Run by

Indiana University

People needed

29

Starts

2006-10-01

Expected to finish

2014-11-01

Last updated by the study team

2016-03-24

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Indiana Univeristy Cancer Center — Indianapolis, Indiana, United States
• University of Pennsylvania:Abramson Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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