Status:
COMPLETED
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
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 irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving...
Detailed Description
OBJECTIVES: * Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck. * Evaluate the to...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma of the head and neck that is considered incurable with surgery or radiotherapy
- Meets one of the following criteria:
- Previously untreated disease
- Newly diagnosed disease with distant metastases
- Recurrent or persistent disease
- Local-regional recurrence/persistence or distant metastases after initial treatment with surgery or radiotherapy
- No locally advanced unresectable disease that was not previously treated with radiotherapy
- Bidimensionally measurable disease
- If the only measurable disease is within the radiotherapy port, there must be biopsy-proven recurrence ≥ 8 weeks after the completion of radiotherapy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Creatinine clearance ≥ 50 mL/min
- SGOT ≤ 3 times upper limit of normal
- Serum bilirubin \< 1.5 mg/dL
- Granulocytes ≥ 1,500/mm \^3
- Platelet count \> 100,000/mm\^3
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant detectable infection
- No co-morbid disease unless under adequate control
- No other cancer within the past 3 years except basal cell or squamous cell skin cancer or early-stage prostate cancer
Exclusion
- Pregnant or lactating women
- Not specified
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from any prior major surgery
- No prior chemotherapy for recurrent or metastatic disease
- Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy ≥ 3 months prior to recurrence will be considered chemotherapy-naive
- Patients who completed neoadjuvant, concurrent, or adjuvant chemotherapy \< 3 months prior to recurrence will be considered chemotherapy failures
- No prior therapy with topotecan or irinotecan hydrochloride
- At least 4 weeks since prior biologic therapy (e.g., interleukin-2, interferon, megestrol acetate)
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00639769
Start Date
February 1 2002
End Date
July 1 2008
Last Update
September 14 2012
Active Locations (8)
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1
Central Georgia Hematology Oncology Associates, P.C.
Macon, Georgia, United States
2
Erlanger Health System
Chattanooga, Tennessee, United States
3
Jackson-Madison County Hospital
Jackson, Tennessee, United States
4
East Tennessee State University
Johnson City, Tennessee, United States