October 26, 2006 |
May 11, 2009 |
October 2006 |
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 ] |
Same as current |
Complete list of historical versions of study NCT00393861 on ClinicalTrials.gov Archive Site |
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 ] |
Same as current |
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Study of Oxaliplatin Plus Bevacizumab in Germ Cell Tumor Patients |
Phase II Study of Oxaliplatin Plus Bevacizumab Salvage Chemotherapy in Patients With Germ Cell Tumors |
The purpose of this study is to evaluate the effectiveness of oxaliplatin and bevacizumab in patients with refractory or relapsed germ cell tumors. |
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. |
Phase II |
Interventional |
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Neoplasms, Germ Cell and Embryonal |
Drug: Bevacizumab and Oxaliplatin |
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Recruiting |
18 |
November 2012 |
October 2010 (final data collection date for primary outcome measure) |
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.
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Both |
18 Years and older |
No |
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United States |
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NCT00393861 |
Lawrence Einhorn, MD/ Principal Investigator, Indiana University Cancer Center |
IUCRO-0166, AVF4003s |
Indiana University School of Medicine |
Genentech |
Principal Investigator: |
Lawrence Einhorn, MD |
Indiana Univeristy School of Medicine |
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Indiana University |
May 2009 |