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Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients
This study is currently recruiting participants.
Verified by Indiana University, November 2008
First Received: October 26, 2006   Last Updated: November 7, 2008   History of Changes
Sponsors and Collaborators: Indiana University School of Medicine
Genentech
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00393861
  Purpose

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


Condition Intervention Phase
Neoplasms, Germ Cell and Embryonal
Drug: Bevacizumab and Oxaliplatin
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Oxaliplatin Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The primary objective is to determine the 12 month continuous disease-free survival rate of oxaliplatin and bevacizumab in refractory germ cell tumors. [ Time Frame: 12 month post completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to determine the partial and complete response rates and duration of remission [ Time Frame: completion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2006
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Bevacizumab and Oxaliplatin
    Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393861

Contacts
Contact: Jackie Brames, RN 317-274-7929 mjbrames@iupui.edu
Contact: Erin Pennington 317-278-4271 erpennin@iupui.edu

Locations
United States, Indiana
Indiana Univeristy Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jackie Brames, RN     317-274-7929     mjbrames@iupui.edu    
Principal Investigator: Lawrence Einhorn, MD            
United States, Pennsylvania
University of Pennsylvania:Abramson Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Janelle Robinson     215-662-7398     Janelle.Robinson@uphs.upenn.edu    
Principal Investigator: David Vaughn, MD            
Sponsors and Collaborators
Indiana University School of Medicine
Genentech
Investigators
Principal Investigator: Lawrence Einhorn, MD Indiana Univeristy School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana University Cancer Center ( Lawrence Einhorn, MD/ Principal Investigator )
Study ID Numbers: 0609-11, IUCRO-0166, AVF4003s
Study First Received: October 26, 2006
Last Updated: November 7, 2008
ClinicalTrials.gov Identifier: NCT00393861     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Germ Cell Tumor
Germ Cell Cancer

Study placed in the following topic categories:
Oxaliplatin
Neoplasms, Germ Cell and Embryonal
Malignant Germ Cell Tumor
Bevacizumab
Angiogenesis Inhibitors

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Oxaliplatin
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on May 07, 2009