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

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: gemcitabine; Drug: paclitaxel

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00100789

S0329 (Other Identifier)

CDR0000407644

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

67 participants in 1 patient group

gemcitabine paclitaxel combination

Experimental group

Treatment:

Drug: paclitaxel

Drug: gemcitabine