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

NCT ID: NCT00081042

Last Updated: 2013-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2010-01-31

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.

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 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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage III melanoma; stage IV melanoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Antoni Ribas, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

References

Hersh EM, O'Day SJ, Ribas A, Samlowski WE, Gordon MS, Shechter DE, Clawson AA, Gonzalez R. A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer. 2010 Jan 1;116(1):155-63. doi: 10.1002/cncr.24720.

Reference Type: RESULT

PMID: 19877111 (View on PubMed)

Other Identifiers

UCLA-0309060

Identifier Type: -

Identifier Source: secondary_id

ABI-CA014

Identifier Type: -

Identifier Source: secondary_id

CDR0000358804

Identifier Type: -

Identifier Source: org_study_id