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

NCT00182806 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000441226RPCI-I-31204
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Objective response (complete, partial, and stable disease)

Secondary Outcomes (1)

• Median time to progression

Interventions

gemcitabine hydrochloride DRUG

IV over 30 minutes on days 2 and 9. Courses repeat every 21 days.

irinotecan hydrochloride DRUG

IV over 90 minutes on days 1 and 8. Courses repeat every 21 days.

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• 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.

  PMID: 18594219 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Nithya Ramnath, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: July 1, 2008
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

US (1)