Status:
UNKNOWN
Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye
Lead Sponsor:
Institut Curie
Conditions:
Intraocular Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibod...
Detailed Description
OBJECTIVES: Primary * To evaluate the efficacy of temozolomide in combination with bevacizumab in treating patients with metastatic uveal melanoma not amenable to curative surgery. Secondary * To ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed uveal melanoma
- Metastatic disease
- Measurable disease, defined as ≥ 1 measurable lesion as measured by RECIST criteria
- No curative surgical treatment envisaged
- No active brain metastases (if clinical suspicion, must have a brain CT scan within 28 days)
- PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy ≥ 12 weeks
- Hemoglobin ≥ 10 g/dL
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 50 mL/min
- Proteinuria \< 2+ on urinary dipstick OR 24-hour proteinuria ≤ 1 g
- Total bilirubin ≤ 1.5 times ULN
- AST/ALT ≤ 2.5 times ULN
- Lactate dehydrogenase ≤ 5 times ULN
- INR and PT ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No uncontrolled active disease or at risk of bleeding, ongoing infection, or clotting disorder
- No other cancer except for skin carcinomas and cervical carcinoma in situ
- No pre-existing peripheral neuropathy, \> grade 2 (NCI CTC-AE)
- No failure to comply with the medical follow-up of the study for geographical, social, or psychological reasons
- No recent thrombophlebitis or pulmonary embolism within the past 6 months
- No uncontrolled hypertension (systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg)
- No concurrent active cardiovascular disease, uncontrolled by medical treatment within the past 6 months, including any of the following:
- Unstable angina
- Severe hypertension
- Severe arrhythmia
- No unhealed wound, active peptic ulcer, bone fracture, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No known hypersensitivity to bevacizumab, temozolomide, or their excipients
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- At least 24 hours since insertion of central infusion port
- More than 5 days since prior non-hepatic biopsy or aspiration cytology
- More than 10 days since prior aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or full-dose oral or parenteral anticoagulant therapy, except prophylactic anticoagulant therapy prior to inclusion in the study
- More than 14 days since prior laparoscopic liver biopsy
- More than 28 days since prior major surgery
- More than 28 days since prior participation in another study with experimental treatment
- No other concurrent anticancer treatment
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01217398
Start Date
October 1 2009
Last Update
August 26 2013
Active Locations (1)
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1
Institut Curie Hopital
Paris, France, 75248