Status:
COMPLETED
Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and ABI-007, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ...
Detailed Description
OBJECTIVES: Primary * Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation (ABI-007) in patients with unresectable stage IV melanoma who...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable stage IV melanoma
- Measurable disease
- Must have formalin-fixed, paraffin-embedded tumor tissue available for secreted protein acidic and rich in cysteine (SPARC) analysis pre-treatment (Mayo Clinic patients must be willing to submit a repeat biopsy at time of tumor progression)
- Brain metastases allowed provided they were previously treated with no progression for ≥ 3 months
- Patients with known brain metastases may receive concurrent steroid treatment
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (may be transfused to meet this requirement)
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN (elevated bilirubin allowed in patients with documented Gilbert's syndrome)
- AST ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 month after completion of study therapy
- No uncontrolled intercurrent illness including, but not limited to, the following:
- Active infection
- Congestive heart failure (New York Heart Association class III-IV heart disease)
- No peripheral neuropathy ≥ grade 2
- No other malignancy within the past 5 years except basal cell or squamous cell carcinoma of the skin previously treated with local resection only or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- At least 4 weeks since prior radiotherapy
- At least 4 weeks since prior interferon or interleukin-2
- At least 4 weeks since prior chemotherapy (cohort 1 )
- No prior chemotherapy in the metastatic setting (cohort 2)
- No prior treatment for melanoma with any of the following agents:
- Platinum chemotherapy (e.g., carboplatin or cisplatin)
- Taxanes (e.g., paclitaxel or docetaxel)
- Paclitaxel albumin-stabilized nanoparticle formulation (ABI-007)
- No other concurrent chemotherapy
- No other concurrent investigational agents
- No concurrent radiotherapy, including palliative radiotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00404235
Start Date
October 1 2006
End Date
March 1 2010
Last Update
October 16 2018
Active Locations (156)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
3
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
4
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701