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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT00017251
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed extensive stage small cell lungcancer
* No active CNS disease
* CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 2 months
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* AST and ALT no greater than 2.5 times upper limit of normal (ULN)
* PT and PTT no greater than 1.5 times ULN
* Creatinine normal
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reactions to compounds of similar chemical or biologic composition to study agents
* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* See Disease Characteristics
* At least 1 week since prior CNS radiotherapy and recovered
* No prior radiotherapy to more than 25% of skeleton
* No other prior anticancer therapy
* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent anticoagulation therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00017251
Study Brief:
Protocol Section:
NCT00017251