An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
OBJECTIVES:
Primary
- Determine the antitumor activity of ABI-007 in patients with inoperable locally
recurrent or metastatic melanoma.
- Determine the safety and tolerability of this drug in these patients.
Secondary
- Determine the time to disease progression, in terms of the rate and duration of
response or stable disease, in patients treated with this drug.
- Determine the survival of patients treated with this drug.
- Determine the effects of this drug on biomarkers of melanoma in these patients.
- Correlate biomarker levels with response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment
cohorts according to prior cytotoxic chemotherapy (previously treated vs
chemotherapy-naïve).
- Cohort I (previously treated): Patients receive ABI-007 IV over 30 minutes on days 1,
8, and 15.
- Cohort II (chemotherapy-naïve): Patients receive a higher dose of ABI-007 as in cohort
I.
In both cohorts, courses repeat every 4 weeks in the absence of disease progression or
unacceptable toxicity.
Patients are followed monthly for 6 months and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per cohort) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed melanoma
- Inoperable locally recurrent or metastatic disease
- Measurable disease
- No lytic or blastic bone metastasis as only evidence of metastasis
- Prior radiotherapy to a target lesion allowed provided there has been clear
progression of disease since completion of radiotherapy
- No active brain metastasis, including leptomeningeal involvement
- Prior brain metastasis allowed provided the disease is in complete remission for
at least 1 month after therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the
absence of liver metastasis)
- Bilirubin ≤ 1.5 mg/dL
Renal
- Creatinine ≤ 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception 1 month before and during
study participation
- No pre-existing peripheral neuropathy ≥ grade 2
- No prior allergy or hypersensitivity to study drug
- No concurrent clinically significant illness
- No other concurrent active malignancy
- No serious medical risk factors involving any of the major organ systems that would
preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Recovered from prior chemotherapy
- More than 4 weeks since prior cytotoxic chemotherapy
- At least 3 weeks since prior anthracyclines
- No concurrent taxane or anthracyclines
- No concurrent doxorubicin
Endocrine therapy
- No concurrent steroids except as needed for hypersensitivity to study drug
Radiotherapy
- See Disease Characteristics
- Concurrent radiotherapy to a symptomatic non-target lesion (including recurrent or
new brain metastases that develop during study participation) allowed
Surgery
- Not specified
Other
- More than 4 weeks since prior investigational drugs and recovered
- No other concurrent anticancer therapy
- No concurrent participation in another clinical study
- No other concurrent investigational therapies
- No concurrent ritonavir, saquinavir, indinavir, or nelfinavir
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Antoni Ribas, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000358804
NCT ID:
NCT00081042
Start Date:
February 2004
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
