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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00003111 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: irinotecan hydrochloride Drug: paclitaxel Procedure: neoadjuvant therapy Procedure: surgical procedure Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC |
| Enrollment: | 10 |
| Study Start Date: | April 1997 |
| Study Completion Date: | April 2004 |
OBJECTIVES:
OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until disease progression. Once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. Following resection, patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours. Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks.
Patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival.
PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| Study Chair: | John R. Murren, MD | Yale University |
More Information
| ClinicalTrials.gov Identifier: | NCT00003111 History of Changes |
| Other Study ID Numbers: | CDR0000065855, YALE-HIC-9317, NCI-G97-1345 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 21, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IIIA non-small cell lung cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Irinotecan Cisplatin Carboplatin Paclitaxel |
Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
