Docetaxel and Vinorelbine Plus Sargramostim in Malignant Melanoma - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00256282

Purpose

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.

Condition	Intervention	Phase
Metastatic Melanoma	Drug: Vinorelbine Drug: Docetaxel Drug: Sargramostim	Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Vinorelbine Granulocyte-macrophage colony-stimulating factor Docetaxel Sargramostim Vinorelbine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Malignant Melanoma

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Assess the qualitative and quantitative toxicities of docetaxel and vinorelbine [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	April 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

30 mg/m2 IV over 6-10 min every 14 days

40mg/m2 IV over 1 hour every 14 days

250 mcg/m2 SQ QD x 10 days

Eligibility

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

Criteria

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
- 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
- SGOT and 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
Pregnant or nursing women
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256282

Contacts

Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center

1-877-UC-STUDY

UCstudy@uci.edu

Locations

United States, California
Chao Family Comprehensive Cancer Center	Recruiting
Orange, California, United States, 92868
Principal Investigator: John Fruehauf, MD

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

John Fruehauf, MD

Chao Family Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	University of California, Irvine Medical Center ( John Fruehauf, MD )
Study ID Numbers:	UCI 02-23
Study First Received:	November 17, 2005
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00256282 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

Metastatic Melanoma

Study placed in the following topic categories:

Docetaxel
Neuroectodermal Tumors
Vinorelbine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Nevus
Antineoplastic Agents, Phytogenic
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Docetaxel

Neuroectodermal Tumors
Neoplasms
Vinorelbine
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009