Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
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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 2 |
| 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:
- Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer.
- Investigate the phenotypic changes induced in the tumor by this treatment.
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:
- Histologically confirmed, previously untreated stage IIIa (T1-2 N2 M0) non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Total bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine clearance at least 55 mL/min
Other:
- Not HIV positive
- No active infections
- Not pregnant or lactating
- Effective contraception required of fertile patients during study participation
- No coexisting medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiation therapy
- No concurrent radiation therapy
Surgery:
- Not specified
Other:
- No concurrent use of investigational agents during study participation
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
Additional Information:
No publications provided
| 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 |
Keywords provided by Yale University:
|
stage IIIA non-small cell lung cancer |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 18, 2013