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:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT00022594
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the head and neck
* Metastatic or loco-regionally recurrent disease
* No undifferentiated or non-keratinizing carcinomas including lymphoepitheliomas
* No tumors of the nasal or paranasal cavities or of the nasopharynx
* Measurable disease
* No clinical symptomatic evidence of brain or leptomeningeal metastases
* Ineligible for loco-regional treatment after chemotherapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal:
* Creatinine no greater than 1.5 times ULN
* No uncontrolled hypercalcemia
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 30 days after study
* No known hypersensitivity to systemic liposomal formulations or compounds chemically related to study drug
* No uncontrolled systemic disease or infection
* No psychological, familial, sociological, or geographical condition that would preclude study
* No other prior or concurrent malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent anticancer biological therapy or immune response modifiers
* No concurrent prophylactic hematopoietic growth factors
Chemotherapy:
* See Disease Characteristics
* No prior chemotherapy for recurrent disease
* No prior therapy with camptothecin analogues
* At least 8 weeks since prior neoadjuvant or adjuvant chemotherapy
* No other concurrent anticancer cytotoxic therapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 8 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* At least 30 days since prior experimental drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00022594
Study Brief:
Protocol Section:
NCT00022594