Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0309060 ABI-CA014, NCT00081042

Objectives

Primary

1. Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma.
2. Determine the safety and tolerability of this drug in these patients.

Secondary

1. Determine the time to disease progression, in terms of the rate and duration of response or stable disease, in patients treated with this drug.
2. Determine the survival of patients treated with this drug.
3. Determine the effects of this drug on biomarkers of melanoma in these patients.
4. Correlate biomarker levels with response in patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

A total of 24-70 patients (12-35 per cohort) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Antoni Ribas, MD, Protocol chair		Ph: 310-206-3928; 888-798-0719 Email: aribas@mednet.ucla.edu

Registry Information
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
Trial Start Date		2004-02-06
Registered in ClinicalTrials.gov		NCT00081042
Date Submitted to PDQ		2004-02-23
Information Last Verified		2005-05-05
NCI Grant/Contract Number		P30-CA16042

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