Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients

NCT00393861 | Completed Phase 2 Results DMC

• 3 other identifiers: 0609-11; IUCRO-0166IUCRO-0166AVF4003s
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms, Germ Cell and Embryonal

Keywords

Germ Cell Tumor; Germ Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Twelve Month Disease-free Survival Rate

  The percent of patients being disease-free at 12 months after treatment initiation will be estimated with a 90% exact binomial confidence interval for the percent of patients receiving drug.

  12 month post completion of treatment

Secondary Outcomes (3)

• Objective Response Rate (Complete and Partial Response)

  completion of study, up to 5 years

• Duration of Remission (CR + PR)

  completion of study, up to 5 years

• Overall Survival

  completion of study, up to 5 years

Study Arms (1)

oxaliplatin & bevacizumab

EXPERIMENTAL

Drug: Bevacizumab and Oxaliplatin

Interventions

Bevacizumab and Oxaliplatin DRUG

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

oxaliplatin & bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Indiana University: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Indiana Univeristy Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Pennsylvania:Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Bevacizumab; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Lawrence H. Einhorn, M.D.
• Organization: IndianaU

leinhorn@iu.edu

(317) 944-0920

Study Officials

• Lawrence Einhorn, MD

  Indiana Univeristy School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 30, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2014
• Last Updated: March 24, 2016
• Results First Posted: January 29, 2015

Record last verified: 2016-02

Locations

US (2)