Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients

NCT ID: NCT00393861

Last Updated: 2016-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2014-11-30

Brief Summary

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

Detailed Description

This study proposes to look at the established combination of oxaliplatin and bevacizumab as used in colorectal cancer in refractory germ cell tumor patients. Oxaliplatin is a drug of known activity. Although bevacizumab has no single agent data, it combines dramatically well with numerous chemotherapy drugs, such as oxaliplatin increasing response rates and improving survival. Furthermore, VEG-F appears to be an important target in germ cell tumors as it does in so many other types of solid tumors. We will be using the identical dosages of oxaliplatin + bevacizumab as has been utilized in previously treated colorectal cancer, without the addition of 5-FU + leucovorin. This dose and schedule has been proven to be safe and effective.

Conditions

Neoplasms, Germ Cell and Embryonal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

oxaliplatin & bevacizumab

Group Type: EXPERIMENTAL

Bevacizumab and Oxaliplatin

Intervention Type: DRUG

Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes

Interventions

Bevacizumab and Oxaliplatin

Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Einhorn, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana Univeristy School of Medicine

Locations

Indiana Univeristy Cancer Center

Indianapolis, Indiana, United States

University of Pennsylvania:Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

IUCRO-0166

Identifier Type: OTHER

Identifier Source: secondary_id

AVF4003s

Identifier Type: OTHER

Identifier Source: secondary_id

0609-11; IUCRO-0166

Identifier Type: -

Identifier Source: org_study_id