Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC

• Status: Terminated
• Trial end date: 2017-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leo W. Jenkins Cancer Center
• Treatments: Camptothecin; Cisplatin; Irinotecan

Criteria

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.