Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

NCT00256282 | Completed Phase 2 Results DMC

• 3 other identifiers: UCI 02-232002-2763NCI-2010-00217
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.

Conditions

Metastatic Melanoma

Keywords

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy

  The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan.

  Six months from initial treatment

Secondary Outcomes (1)

• Percentage of Patients Alive at One Year

  1 year

Study Arms (1)

Docetaxel & Vinorelbine + Sargramostim

EXPERIMENTAL

Docetaxel, Vinorelbine, and Sargramostim

Drug: Vinorelbine; Drug: Docetaxel; Drug: Sargramostim

Interventions

Vinorelbine DRUG

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

Also known as: Navelbine, NSC-608210

Docetaxel & Vinorelbine + Sargramostim

Docetaxel DRUG

40mg/m2 IV over 1 hour every 14 days

Also known as: Taxotere, RP56976, NSC-628503

Docetaxel & Vinorelbine + Sargramostim

Sargramostim DRUG

250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days

Also known as: Recombinant GM-CSF, Leukine, Immunex, NSC-613795

Docetaxel & Vinorelbine + Sargramostim

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John P. Fruehauf: lead
• Bayer: collaborator

Study Sites (1)

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Related Publications (1)

• Eroglu Z, Kong KM, Jakowatz JG, Samlowski W, Fruehauf JP. Phase II clinical trial evaluating docetaxel, vinorelbine and GM-CSF in stage IV melanoma. Cancer Chemother Pharmacol. 2011 Oct;68(4):1081-7. doi: 10.1007/s00280-011-1703-z. Epub 2011 Jul 19.

  PMID: 21769667 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

Vinorelbine; Docetaxel; sargramostim

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)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. John P. Fruehauf
• Organization: University of California, Irvine

jfruehau@uci.edu

714-456-5153

Study Officials

• John P. Fruehauf, MD, PhD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: April 1, 2003
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 3, 2018
• Results First Posted: May 3, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)