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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irinotecan hydrochloride
paclitaxel
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Comprehensive Cancer Center
  • Northwestern Connecticut Oncology-Hematology Associates - Torrington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
August 21, 2009
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004924
Brief Title
Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
Official Title
Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Murren, MD
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Northwestern Connecticut Oncology-Hematology Associates - Torrington
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States

12. IPD Sharing Statement

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

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