ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00081042

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ABI-007 works in treating patients with inoperable (unresectable) locally recurrent or metastatic melanoma.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Drug: paclitaxel albumin-stabilized nanoparticle formulation	Phase 2

Detailed Description

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

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Multicenter, Phase II Trial of ABI-007 (A Cremophor® -Free, Protein Stabilized, Nanoparticle Paclitaxel) in Previously Treated Patients With Metastatic Melanoma

Study Start Date :

Feb 1, 2004

Actual Study Completion Date :

Jan 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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