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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT00043927
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent (patient's written understanding of and agreement to participate in this study).
* Patients with confirmed extensive small cell lung cancer (SCLC).
* No prior chemotherapy within 5 years of the diagnosis of SCLC.
* Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
* At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
* At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
Exclusion Criteria:
* Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
* Any active infection.
* Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
* Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
* Use of an investigational drug within 30 days before the first dose of study medication.
* Women who are pregnant or lactating.
* Patients of child-bearing potential who refuse to practice an adequate form of birth control.
* Patients with clinical evidence of any stomach or intestinal (GI) condition.
* Patients requiring treatment with the drug cyclosporin A.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00043927
Study Brief:
Protocol Section:
NCT00043927