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

Melanoma (Skin) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081042
• Other study ID #: CDR0000358804
• Secondary ID: UCLA-0309060ABI-
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2004
• Last updated: December 18, 2013
• Start date: February 2004
• Est. completion date: January 2010

Study information

• Verified date: May 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• paclitaxel albumin-stabilized nanoparticle formulation

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation