An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: February 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location