Phase 2
Completed N=76
Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Melanoma (Skin)
Source: ClinicalTrials.gov NCT00404235 ↗
Enrolled (actual)
76
Serious AEs
11.0%
Results posted
Oct 2018
Primary outcomePrimary: Tumor Response Rate, as Measured by RECIST Criteria — 8.8; 25.6 percentage of participants
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 more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response Rate, as Measured by RECIST Criteria |
8.8; 25.6 | — |
| SECONDARY Survival Time |
10.9; 11.1 | — |
| SECONDARY Time to Disease Progression |
4.1; 4.5 | — |
| SECONDARY Duration of Response |
3.5; 12.1 | — |
| SECONDARY Number of Treatment Cycles Administered |
4; 4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00404235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.