Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer

NCT00004924 | Completed Phase 2

• 3 other identifiers: CDR0000067608YALE-HIC-10740NCI-G00-1701
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Interventions

irinotecan hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Northwestern Connecticut Oncology-Hematology Associates - Torrington

Torrington, Connecticut, 06790, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Irinotecan; Paclitaxel

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• John R. Murren, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: March 1, 1999
• Study Completion: February 1, 2006
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

US (2)