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Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
irinotecan hydrochloride
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, 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 or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: Stage IIIA or IIIB disease Progressive disease Stage IV disease Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy Measurable or evaluable disease, as defined by 1 of the following criteria: At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan Lesions apparent on CT scan that do not meet the criterion for measurability Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 12 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 1.5 times normal Alkaline phosphatase < 1.5 times normal Bilirubin ≤ 1.3 mg/dL Renal Creatinine ≤ 1.6 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular No unstable angina No congestive heart failure No myocardial infarction within the past 3 months No life-threatening ventricular arrhythmia requiring maintenance therapy Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment No uncontrolled seizure disorder No uncontrolled diabetes mellitus No active infection requiring systemic therapy No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other unstable or serious condition PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy Prior irinotecan allowed No prior gemcitabine No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 1 month since prior participation in another clinical trial using an investigational agent No other concurrent investigational agents

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Objective response (complete, partial, and stable disease)

Secondary Outcome Measures

Median time to progression

Full Information

First Posted
September 15, 2005
Last Updated
March 5, 2012
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00182806
Brief Title
Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine. Secondary Determine the median time to progression in patients treated with this regimen. OUTLINE: This a non-randomized, open-label, multicenter study. Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 1 month and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Description
IV over 30 minutes on days 2 and 9. Courses repeat every 21 days.
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Description
IV over 90 minutes on days 1 and 8. Courses repeat every 21 days.
Primary Outcome Measure Information:
Title
Objective response (complete, partial, and stable disease)
Secondary Outcome Measure Information:
Title
Median time to progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: Stage IIIA or IIIB disease Progressive disease Stage IV disease Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy Measurable or evaluable disease, as defined by 1 of the following criteria: At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan Lesions apparent on CT scan that do not meet the criterion for measurability Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 12 weeks Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 1.5 times normal Alkaline phosphatase < 1.5 times normal Bilirubin ≤ 1.3 mg/dL Renal Creatinine ≤ 1.6 mg/dL OR Creatinine clearance ≥ 50 mL/min Cardiovascular No unstable angina No congestive heart failure No myocardial infarction within the past 3 months No life-threatening ventricular arrhythmia requiring maintenance therapy Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment No uncontrolled seizure disorder No uncontrolled diabetes mellitus No active infection requiring systemic therapy No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other unstable or serious condition PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy Prior irinotecan allowed No prior gemcitabine No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery Not specified Other More than 1 month since prior participation in another clinical trial using an investigational agent No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nithya Ramnath, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18594219
Citation
Ramnath N, Yu J, Khushalani NI, Gottlieb RH, Schwarz JK, Iyer RV, Rustum YM, Creaven PJ. Scheduled administration of low dose irinotecan before gemcitabine in the second line therapy of non-small cell lung cancer: a phase II study. Anticancer Drugs. 2008 Aug;19(7):749-52. doi: 10.1097/CAD.0b013e328301c54f.
Results Reference
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Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer

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