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Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00087776
First received: July 13, 2004
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

The primary objective of this trial is to compare the survival of patients with metastatic malignant melanoma treated with Taxoprexin Injection to those treated with Dacarbazine. In addition, the response rate to each drug, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.


Condition Intervention
Malignant Melanoma
Drug: Chemotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Taxoprexin Injection vs. Dacarbazine in Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Estimated Enrollment: 575
Study Start Date: October 2002
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have malignant melanoma, and documented metastatic disease.
  • Patients must have at least one unidimensionally measurable lesion.
  • Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression.
  • At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during immunotherapy.
  • At least 4 weeks (28 days) since any prior radiotherapy.
  • Lesions being used to assess disease status may not have been radiated.
  • Patients must have ECOG performance status of 0 - 2.
  • Patients must be >= 18 years of age.
  • Patients must have adequate renal and liver function
  • Patients must have adequate bone marrow function.
  • Life expectancy of at least 3 months.
  • Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion Criteria:

  • Patients who have received prior therapy with any taxane or dacarbazine.
  • Patients whose primary site is the eye.
  • Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers cured by surgery alone with a disease-free survival longer than 5 years.
  • Patients with uncontrolled brain metastasis.
  • Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
  • Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
  • Patients with current peripheral neuropathy of any etiology that is greater than grade 1.
  • Patients with unstable or serious concurrent medical conditions are excluded.
  • Patients with a known hypersensitivity to Cremophor.
  • Patients must not have had recent major surgery within the past 14 days or large field radiation therapy, chemotherapy, endocrine therapy in the last 28 days, or biologic therapy in the last 42 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087776

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00087776     History of Changes
Other Study ID Numbers: P01-02-17
Study First Received: July 13, 2004
Last Updated: March 16, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 27, 2014