Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC

NCT02275806 | Terminated Phase 2 DMC

• 1 other identifier: LJCC 2014-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lung Neoplasms, Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan

  Three years after the last patient has completed treatement

• Estimate the progression-free survival

  Three years after the last patient has completed treatement.

Secondary Outcomes (2)

• Compare the survival of patients treated with cisplatin/irinotecan with historical controls using cisplatin/etoposide.

  Three years after the last patient has completed treatment.

• Measure toxicities and compliance of patients on this regimen

  Thirty days after completing treatment, averaging 100 days.

Study Arms (1)

All enrolled patients

OTHER

Induction Chemotherapy Cycle 1 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 1 and 8 Concurrent Chemotherapy Cycles 2-4 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 22 and 29, days 43 and 50, and days 64 and 71 along with radiation therapy of 60-70 Gy in 2 GY fractions on days 22 -71.

Drug: Irinotecan; Drug: Cisplatin

Interventions

Irinotecan DRUG

Also known as: Camptosar, camptothecin-11, CPT-11

All enrolled patients

Cisplatin DRUG

Also known as: Platinol, CDDP

All enrolled patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead

Study Sites (1)

Leo W Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Irinotecan; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Paul Walker, MD, FACP

  Brody School of Medicine at East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2014
• Primary Completion: September 27, 2017
• Study Completion: September 27, 2017
• Last Updated: August 21, 2019

Record last verified: 2018-10

Locations

US (1)