Informations générales (source: ClinicalTrials.gov)
Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma
Interventional
Phase 2
Institut Curie (Voir sur ClinicalTrials)
octobre 2009
29 juin 2024
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 antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells
and help kill them or carry tumor-killing substances to them. Giving temozolomide
together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to
see how well they work in treating patients with metastatic melanoma of the eye.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact Person | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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