Phase 2
N=40
Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00639769 ↗Enrolled (actual)
40
Serious AEs
67.5%
Results posted
Dec 2011
Primary outcome: Primary: Patient Response — 11; 15; 6; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); irinotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Response |
11; 15; 6; 0 | — |
| SECONDARY Number of Patients With Each Worst-grade Toxicity |
2; 12; 21; 10; 1 | — |
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 more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.
Eligibility Criteria
Inclusion Criteria
- 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 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 Criteria
-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)
Data sourced from ClinicalTrials.gov (NCT00639769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.