Paclitaxel and Irinotecan in Treating Patients With Advanced 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: This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: irinotecan hydrochloride Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer |
| Enrollment: | 28 |
| Study Start Date: | March 1999 |
| Study Completion Date: | February 2006 |
OBJECTIVES:
- Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer.
OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest. Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic non-small cell lung cancer for which no curative therapy exists
- Stage IIIB with pleural effusion allowed
- Measurable or evaluable disease
- CNS metastases allowed if disease stable at least 4 weeks following completion of surgery and/or radiotherapy and no anticonvulsant required
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
- SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver)
Renal:
- Creatinine clearance at least 70 mL/min
Other:
- No other malignancies within past 3 years except nonmelanomatous skin cancer and carcinoma in situ of the cervix
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective birth control
- No active infection
- No concurrent medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior systemic chemotherapy for lung cancer
- No prior irinotecan or paclitaxel
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior wide field radiotherapy
- No prior radiotherapy to greater than 20% of bone marrow allowed
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Contacts and Locations| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| Northwestern Connecticut Oncology-Hematology Associates - Torrington | |
| Torrington, Connecticut, United States, 06790 | |
| Study Chair: | John R. Murren, MD | Yale University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004924 History of Changes |
| Other Study ID Numbers: | CDR0000067608, YALE-HIC-10740, NCI-G00-1701 |
| Study First Received: | March 7, 2000 |
| Last Updated: | August 21, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
stage IIIB non-small cell lung cancer stage IV 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 Paclitaxel Irinotecan Camptothecin |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013