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Clinical Trials/NCT00182806
NCT00182806CompletedPhase 2

Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy

Roswell Park Cancer Institute2 sites in 1 country38 target enrollmentStarted: September 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
38
Locations
2
Primary Endpoint
Objective response (complete, partial, and stable disease)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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:
  • •18 and over
  • •Performance status
  • •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
  • •AST and ALT ≤ 1.5 times normal
  • •Alkaline phosphatase < 1.5 times normal
  • •Bilirubin ≤ 1.3 mg/dL
  • •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
  • •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
  • +5 more not shown

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Objective response (complete, partial, and stable disease)

Secondary Outcomes

  • Median time to progression

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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