Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00639769
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 \< 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 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00639769
Study Brief:
Protocol Section:
NCT00639769