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 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT00005850
Eligibility Criteria:
Eligibility Criteria:
1. Histologic Documentation: All patients must have histologically or cytologically documented, non-small cell carcinoma of the lung (adenocarcinoma, large cell, squamous, or mixtures of these types).
2. Extent of Disease: Stage IIIB/IV cancer by the international staging system or any Stage I-IIIA otherwise eligible patient with recurrent or progressive NSCLC after surgery or radiotherapy.
* Patients with Stage IIIB because of a malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes are eligible (IIIB patients eligible for CALGB protocols of combined chemotherapy and chest irradiation are not eligible.
* Patients with known CNS metastases are not eligible.
3. Measurable or Non-Measurable Disease
* Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
* Non-measurable Disease: Only those non-measurable disease patients with ill-defined masses associated with post-obstructive changes and diffuse parenchymal malignant disease are eligible. All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions, are not eligible.
Lesions that are considered non-measurable include the following:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
4. Prior Treatment:
* No prior chemotherapy.
* ≥ 2 weeks since radiation therapy.
* No antidepressant treatment (eg, selective serotonin reuptake inhibitors, tricyclics, novel antidepressants, St. John's Wort or monoamine oxidase inhibitors) currently or within the last month.
5. If the patient requires pain medication, pain must be managed with non-codeine preparations, including but not limited to: acetaminophen, any morphine based preparation (short or long acting), hydromorphone, fentanyl, levorphanol or methadone.
6. CTC Performance Status 0-1.
7. Non-pregnant and non-nursing because of significant risk to the fetus/infant.
8. Required Initial Laboratory Data:
* Granulocytes ≥ 1,500/µl
* Platelet count ≥ 100,000/µl
* Serum creatinine ≤ 1.5 mg/dl or Calculated CrCl ≥ 60 ml/min
* Bilirubin ≤ 2.0 x Upper Limit of Normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.0 x ULN
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00005850
Study Brief:
Protocol Section:
NCT00005850