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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT00798603
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed nonsquamous cell non-small cell lung cancer (NSCLC)
* Stage IIIB (with pleural effusion) or IV disease
* Squamous cell carcinomas not allowed
* Adenosquamous histology allowed
* Clinically significant effusion (e.g., symptomatic pleural effusion or ascites) allowed provided it is drained before study treatment
* No symptomatic pleural and/or peritoneal effusion (≥ grade 2 dyspnea, as defined by NCI CTCAE v3.0 criteria) that is not amenable to drainage
* If effusion produces clinically significant measurable objective changes, such as hypoxia or estimated volume \> 500 mL, effusion should be drained even if asymptomatic
* Measurable disease, defined as ≥ 1 lesion with longest diameter ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT scan
* If the sole site of disease is in a previously irradiated field, must have evidence of disease progression/recurrence within the irradiated field OR presence of a new lesion outside the irradiated field
* No symptomatic, untreated, or uncontrolled CNS metastases
* CNS metastases that were previously treated with whole brain radiotherapy (WBRT) allowed
* Willing to enroll in NCCTG-N0392
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
* AST and ALT ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)
* Creatinine clearance ≥ 45 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* Able to take folic acid, vitamin B\_12 supplementation, or dexamethasone
* Able to complete questionnaire(s) alone or with assistance
* Willing to provide biologic specimens as required by the study
* Willing to return to NCCTG participating center for follow-up
* No clinically significant infection
* No serious, nonhealing wounds, ulcers, or bone fractures
* No seizure disorder
* No second primary malignancy within the past 5 years, except for any of the following:
* Carcinoma in situ of the cervix
* Nonmelanomatous skin cancer
* History of melanoma allowed only if diagnosed and definitively treated ≥ 5 years ago with no subsequent evidence of recurrence
* Low-grade (Gleason score ≤ 6) localized prostate cancer (no nodal involvement)
* Previously treated stage I breast cancer
* No concurrent severe and/or uncontrolled medical condition, including any of the following:
* Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
* Angina pectoris
* Congestive heart failure within the past 3 months, unless ejection fraction \> 40%
* Myocardial infarction within the past 6 months
* Cardiac arrhythmia
* Diabetes mellitus
* Interstitial pneumonia or extensive, symptomatic interstitial fibrosis of the lung
* Active or recent history of hemoptysis \> ½ teaspoon per event
* Ongoing or active infection
* Psychiatric illness/social situation that would limit compliance with study requirements
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 12 months
* No diverticulitis within the past 12 months
* No stroke within the past 6 months
* No significant traumatic injury within the past 8 weeks
* Not at greater than normal risk of bleeding
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior radiotherapy to \> 25% of bone marrow
* More than 2 weeks since prior radiotherapy and recovered (alopecia allowed)
* At least 2 weeks since prior WBRT
* At least 3 days since prior gamma knife radiosurgery (without WBRT) for brain metastases
* More than 4 weeks since prior administration of live or attenuated viral vaccine
* More than 8 weeks since prior major surgery (e.g., laparotomy) or open biopsy (\> 4 weeks since minor surgery)
* Insertion of a vascular access device allowed
* No prior chemotherapy or systemic therapy for advanced lung cancer, except neoadjuvant or adjuvant chemotherapy
* No NSAID's 2 days prior to (5 days for long-acting NSAID's), the day of, and 2 days following protocol treatment
* More than 12 months since prior neoadjuvant therapy, adjuvant therapy, systemic chemotherapy, chemoradiotherapy, immunotherapy, or biologic therapy
* No concurrent anticoagulants
* Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Maximum Age:
120 Years
Study:
NCT00798603
Study Brief:
Protocol Section:
NCT00798603