Status:
COMPLETED
S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Givi...
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00100789
Start Date
January 1 2005
End Date
February 1 2008
Last Update
October 1 2012
Active Locations (123)
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1
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36202
2
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
3
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
4
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220