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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: | 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
| Study ID Numbers: | CDR0000065855, YALE-HIC-9317, NCI-G97-1345 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003111 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIA non-small cell lung cancer |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Irinotecan Physiological Effects of Drugs Neoplasms by Site Cisplatin Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors |
Carboplatin Antimitotic Agents Camptothecin Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Paclitaxel Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
