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A Randomized Phase II Trial of Temozolomide (TMZ) and Bevacizumab or ABI-007 (ABX)/Carboplatin (CBDCA) and Bevacizumab in Patients With Unresectable Stage IV Malignant Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Randomized Phase II Trial of Temozolomide (TMZ) and Bevacizumab or ABI-007 (ABX)/Carboplatin (CBDCA) and Bevacizumab in Patients With Unresectable Stage IV Malignant Melanoma



- To assess the anti-tumor activity, in terms of the percentage of patients who are
treated with these regimens and who are progression-free at 6 months.

- To assess the safety profile of each treatment regimen.


- To estimate the response rate in patients treated with these regimens.

- To estimate the distribution of progression-free survival time and overall survival
time of patients treated with these regimens.


- To examine the impact of therapy on angiogenesis and immune homeostasis.

OUTLINE: Patients are stratified according to ECOG performance status (0 vs 1) and location
of metastatic disease (M1a [skin or subcutaneous tissue or lymph node only] vs M1b [lung] vs
M1c [other visceral sites]) and randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral temozolomide on days 1-5 and bevacizumab IV over 30-90
minutes on days 1 and 15. (closed to accrual 8/21/09)

- Arm II: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, paclitaxel
albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15,
and carboplatin IV over 30 minutes on day 1.

In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.

Patients undergo blood sample collection periodically for VEGF plasma levels and analysis of
changes in immune homeostasis.

Beginning at study entry, patients are followed up every 3 months for 2 years and then every
6 months for up to 3 years.

Inclusion Criteria


- Histologic confirmed diagnosis of malignant melanoma

- Stage IV disease

- Not amenable to surgery

- Measurable disease with at least one lesion whose longest diameter can be measured as
≥ 20 mm by CT or MRI scans OR ≥ 10 mm by spiral CT

- No disease that is measurable by physical examination only

- No brain metastases per MRI or CT

- No radiographically documented invasion of adjacent organs (duodenum, stomach, etc.)
or tumor invading major blood vessels


Inclusion criteria:

- ECOG performance status 0-1

- Life expectancy ≥ 4 months

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL (transfusion allowed)

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL (unless Gilbert syndrome)

- AST ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Urine protein:creatinine ratio < 1.0 at screening OR proteinuria < 2+ by urine
dipstick or protein ≤ 1 g by 24-hour urine collection

- Negative serum pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

Exclusion criteria:

- Active infection requiring parenteral antibiotics

- Poorly controlled high blood pressure (≥ 150 mm Hg systolic and/or 100 mm Hg
diastolic) despite treatment

- NYHA class II-IV congestive heart failure

- Serious cardiac arrhythmia requiring medication

- Myocardial infarction or unstable angina within the past 6 months

- Clinically significant peripheral vascular disease

- Deep venous thrombosis or pulmonary embolus within the past year

- Active bleeding or pathological conditions that carry high risk of bleeding (e.g.,
known esophageal varices)

- Serious, non-healing wound (including wounds healing by secondary intention), ulcer
or bone fracture

- Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within the
past 6 months

- History of CNS disease (e.g., primary brain tumor, vascular abnormalities, etc.)

- Clinically significant stroke or TIA within the past 6 months

- Seizures not controlled with standard medical therapy

- Peripheral neuropathy ≥ grade 2

- History of other malignancy within the past 5 years except basal cell or squamous
cell carcinoma of the skin treatable with local resection only or carcinoma in situ
of the cervix

- Significant traumatic injury within the past 4 weeks

- History of hypertensive crisis or hypertensive encephalopathy

- Active or recent (≤ 30 days) history of hemoptysis (≥ ½ teaspoon of bright red blood
per episode)

- Known hypersensitivity to any of the components of bevacizumab

- Known to be HIV positive

- Current or known history of hepatitis


- Prior adjuvant chemotherapy and/or immunotherapy for this cancer allowed

- No prior treatment with agents disrupting VEGF activity (i.e., bevacizumab,
VEGF-trap, anti-VEGFR Mab)

- No ongoing need for full-dose oral or parenteral anticoagulation

- No ongoing anti-platelet treatment other than low-dose aspirin (i.e., aspirin 81 mg

- No other investigational agents within the past 4 weeks

- No major surgical procedure or open biopsy within the past 4 weeks

- No fine needle aspirations or core biopsies within the past 7 days

- No prior chemotherapy in the metastatic setting

- No prior treatment with sunitinib malate or sorafenib

- No prior treatment with any taxane-based chemotherapy

- Patients who have had > 25% of their functional bone marrow irradiated are not
eligible for this trial

- No adjuvant radiation therapy within the past 4 weeks

- More than 2 weeks since prior and no concurrent palliative radiation therapy

- No concurrent major surgical procedure

- No concurrent participation in another clinical study for procedures or agents that
treat the same primary study malignancy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Safety Issue:


Principal Investigator

Svetomir Markovic, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma



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St. Anne Mercy Hospital Toledo, Ohio  43623
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Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
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