Status:
COMPLETED
Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givin...
Detailed Description
OBJECTIVES: Primary * Determine the response rate in patients with previously treated persistent, recurrent, or metastatic squamous cell carcinoma of the head and neck treated with gemcitabine and d...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Metastatic, persistent, or recurrent disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Must have had definitive surgery and/or radiation therapy AND received at least 1, but no more than 2, chemotherapy regimens, either given as primary therapy or adjuvant therapy before or after surgery and/or radiotherapy
- No active or prior CNS metastasis
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- SWOG 0-2
- Life expectancy
- At least 12 weeks
- Hematopoietic
- Granulocyte count \> 1,500/mm\^3
- Hemoglobin ≥ 8 g/dL
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin normal
- Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Renal
- Creatinine \< 1.5 mg/dL
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No peripheral neuropathy ≥ grade 2
- No active infection requiring systemic therapy
- 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 or any other site
- No history of severe hypersensitivity reaction to study drugs or other drugs formulated with polysorbate 80
- No other serious condition that would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- No prior taxane or gemcitabine
- At least 4 weeks since prior chemotherapy and recovered
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- Surgery
- See Disease Characteristics
- Other
- No other concurrent therapy for this disease
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00248560
Start Date
January 1 2005
End Date
June 1 2012
Last Update
March 5 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379