Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00081042
  Purpose

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 Intervention Phase
Melanoma (Skin)
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081042

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Antoni Ribas, MD Jonsson Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000358804, UCLA-0309060, ABI-CA014
Study First Received: April 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00081042  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage III melanoma
stage IV melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Paclitaxel
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009