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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Completed PHASE2 INTERVENTIONAL NCT00100789

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine together with paclitaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel works in treating patients with persistent, recurrent, or metastatic head and neck cancer.

Detailed Description

OBJECTIVES: * Determine overall and progression-free survival probability in patients with persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and paclitaxel. * Determine the confirmed and unconfirmed response (partial and complete) probability in patients with measurable disease treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Patients are followed every 8 weeks until disease progression, every 6 month for 2 years, and then annually for 1 year. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 10-13 months.

Interventions

Name: gemcitabine
Type: DRUG
Description: 3,000 mg/m2 IV over 30 minutes on days 1 and 15 (q28 days).
Name: paclitaxel
Type: DRUG
Description: 150 mg/m2 IV over 1 hour on days 1 and 15 (q 28 day cycle), administered after gemcitabine

Primary Outcomes

Measure: Overall Survival
TimeFrame: 0 - 3 years
Description: Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Trial Information

NCT ID

NCT00100789

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

SWOG Cancer Research Network

Last Updated

December 15, 2025