Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC
This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Aug 21, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Leo W. Jenkins Cancer Center
- Interventions being studied
- Drug: Irinotecan; Drug: Cisplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma adenosquamous and sarcomatoid carcinomas. * Patients with Pancoast tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. Pancoast tumor patients will be so-noted in the registry. * Patients must be ≥ 18 years of age. * Patients with Zubrod (ECOG) performance status ≤ 2. * Adequate hematologic function defined as: ANC ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl. * Patients with weight loss ≤ 20% over the past 3 months. * Patients with a pleural effusion that is proven cytologically negative or is too small to tap. * Women of childbearing potential must agree to practice effective contraception throughout the study and for four weeks after completion of treatment. * Pretreatment evaluations required for eligibility include: * A medical history, physical examination, and assessment of Zubrod performance status within 4 weeks prior to study entry. * CBC with differential and platelet count, and laboratory profile must be completed within 4 weeks prior to study entry. * CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry. * For women of childbearing potential, a serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) must be performed within a week prior to the start of protocol treatment. * Medical Oncology and Radiation Oncology consultation and approval. * Patients must sign a study-specific consent form prior to study entry. Exclusion Criteria: * Small cell carcinomas or carcinoid histology. * History of any malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers. * Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician. * Cytologically malignant effusions. * Radiographic evidence of metastatic disease. * Active pulmonary infection not responsive to antimicrobial therapy. * History of significant or symptomatic interstitial pneumonitis. * Significant symptomatic cardiac disease, for example, unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias. * Patients with \> grade 2 neuropathy. * Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration. * Women of childbearing potential who are unwilling to practice effective contraception throughout the study and for four weeks after completion of treatment. * Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Leo W Jenkins Cancer CenterGreenville, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2019. Always confirm current availability with the study team.