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

NCT00081042 | Completed Phase 2

• 3 other identifiers: CDR0000358804UCLA-0309060ABI-CA014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage III melanoma; stage IV melanoma

Interventions

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related 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: 10.1002/cncr.24720.

  PMID: 19877111 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Taxes

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Antoni Ribas, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: February 1, 2004
• Study Completion: January 1, 2010
• Last Updated: December 19, 2013

Record last verified: 2005-05

Locations

US (1)