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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)

• Recurrent, persistent, or newly diagnosed metastatic disease

• Measurable or non-measurable disease

• No active or prior CNS metastasis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No serious organ dysfunction

• No serious comorbid conditions that would preclude study treatment

• No history of hypersensitivity reaction to products containing polysorbate 80

• No active infection requiring systemic antibiotic therapy

• No symptomatic sensory neuropathy ≥ grade 2

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biologic or immunotherapy for SCCHN

• No concurrent gene therapy for SCCHN

Chemotherapy

• No prior chemotherapy for recurrent or newly diagnosed metastatic disease

• At least 6 months since prior induction or adjuvant chemotherapy

• No more than 1 prior induction or adjuvant regimen

• No prior gemcitabine or taxanes as part of induction, adjuvant, or neoadjuvant chemotherapy

• No other concurrent chemotherapy for SCCHN

Endocrine therapy

• Not specified

Radiotherapy

• At least 28 days since prior radiotherapy and recovered

• No concurrent radiotherapy for SCCHN

Surgery

• Not specified

Other

• No other concurrent therapy for SCCHN