Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00256282
First received: November 17, 2005
Last updated: March 19, 2013
Last verified: March 2013

November 17, 2005
March 19, 2013
April 2003
July 2012   (final data collection date for primary outcome measure)
Evaluate the response rate (confirmed and unconfirmed complete and partial responses) of patients with metastatic melanoma when treated with vinorelbine and docetaxel. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluate the response rate
Complete list of historical versions of study NCT00256282 on ClinicalTrials.gov Archive Site
Assess the qualitative and quantitative toxicities of docetaxel and vinorelbine [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Assess the qualitative and quantitative toxicities
Not Provided
Not Provided
 
Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma

Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000 deaths. This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women. Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%. Complete responses are rare.

Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a 20% response rate but has failed to consistently demonstrate a significant improvement in overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.

Recently, investigators, in an effort to combine the activity of biologic response modifiers with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha et al reported an overall objective response rate of 64% with a 5-day biochemotherapy regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified 5-day biochemotherapy regimen.

The above regimens all have significant toxicities and modest response rates. Clearly, more effective less toxic regimens are needed.

Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against melanoma. Additionally, the combination of both drugs has shown enhanced activity against melanoma.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Melanoma
  • Drug: Vinorelbine
    30 mg/m2 IV over 6-10 min every 14 days
    Other Names:
    • Navelbine
    • NSC-608210
  • Drug: Docetaxel
    40mg/m2 IV over 1 hour every 14 days
    Other Names:
    • Taxotere
    • RP56976
    • NSC-628503
  • Drug: Sargramostim
    250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
    Other Names:
    • Recombinant GM-CSF
    • Leukine
    • Immunex
    • NSC-613795
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than or equal to 18
  • Karnofsky Performance Status (KFS) of greater than or equal to 70
  • Laboratory values (performed in 14 days, inclusive prior to study drug administration):

    • Absolute neutrophil count (ANC) >1500/mm3
    • Platelet count >100,000/mm3
    • Hemoglobin > 10 g/dl
    • Blood urea nitrogen (BUN) and serum creatinine < 0.5 times the upper limit of laboratory normal
    • Total and direct bilirubin < 1.5 times the upper limit of laboratory normal
    • Serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 3 times the upper limit of laboratory normal
    • Alkaline phosphatase < 3 times upper limit of laboratory normal
  • Life expectancy of greater than 12 weeks
  • Written informed consent

Exclusion Criteria:

  • No recovery from all active toxicities of prior therapies
  • Surgery within 1 week prior to study drug administration, providing acute surgical toxicity is resolved
  • Subjects within acute infection treated with intravenous antibiotics
  • Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
  • Concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ (CIS ) of the cervix, basal or squamous cell carcinoma of the skin, and prior malignancies which have not required anit-tumor treatment within the preceding 24 months
  • Known HIV-positivity or AIDS-related illness
  • Women of childbearing potential who are not using an effective method of contraception (eligible patients must have a negative urine pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions)
  • Men who do not use an effective method of contraception.
  • Chemotherapy within four weeks prior to study drug administration or biologic therapy/immunotherapy within two weeks prior to study drug administration
  • Completion of radiation therapy, interstitial brachytherapy, or radiosurgery within 4 weeks prior to study drug administration (patients with brain metastases from melanoma must have completed radiotherapy to the brain at least 3 weeks before study commences)
  • Bone metastases as sole reason for Stage IV disease
  • Karnofsky Performance Status of less than or equal to 60
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00256282
UCI 02-23, 2002-2763, NCI-2010-00217
Yes
Chao Family Comprehensive Cancer Center, University of California, Irvine
University of California, Irvine
Bayer
Principal Investigator: John P. Fruehauf, MD, PhD Chao Family Comprehensive Cancer Center
University of California, Irvine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP