Know Cancer

forgot password

Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma

Phase 2
18 Years
Open (Enrolling)
Intraocular Melanoma

Thank you

Trial Information

Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma



- To evaluate the efficacy of temozolomide in combination with bevacizumab in treating
patients with metastatic uveal melanoma not amenable to curative surgery.


- To determine response rate in these patients.

- To determine duration of response in these patients.

- To determine progression-free survival of these patients.

- To determine overall survival of these patients.

- To determine the safety of treatment with this regimen in these patients.

- To study the CT perfusion imaging for functional imaging of response in these patients.

- To determine the pharmacogenetic influence of constitutional VEGF-A polymorphism on the
efficacy and toxicity of bevacizumab. (ancillary)

OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and 15-21 and bevacizumab
IV over 30-90 minutes on days 8 and 22. Treatment repeats every 28 days for up to 6 courses.
Patients achieving at least stable disease then receive bevacizumab monotherapy IV every 2
weeks as maintenance therapy in the absence of unacceptable toxicity and disease
progression. Patients undergo CT perfusion imaging at baseline, day 28, and at 3 and 6

Blood samples are collected at baseline and then periodically for VEGF-A genetic
polymorphism analysis.

After completion of study treatment, patients are followed up at 1 month.

Inclusion Criteria


- 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)


- 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

- 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

- 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


- 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

- No other concurrent anticancer treatment

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months

Safety Issue:


Principal Investigator

Sophie Piperno-Neumann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Curie



Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • ciliary body and choroid melanoma, medium/large size
  • ciliary body and choroid melanoma, small size
  • iris melanoma
  • metastatic intraocular melanoma
  • stage IV intraocular melanoma
  • Melanoma
  • Uveal Neoplasms