- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004924
Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520-8028
- Yale Comprehensive Cancer Center
-
Torrington, Connecticut, United States, 06790
- Northwestern Connecticut Oncology-Hematology Associates - Torrington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: John R. Murren, MD, Yale University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Paclitaxel
- Irinotecan
Other Study ID Numbers
- CDR0000067608
- YALE-HIC-10740
- NCI-G00-1701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Cancer
-
M.D. Anderson Cancer CenterRecruitingStage III Lung Cancer AJCC v8 | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingStage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingCaregiver | Stage III Lung Cancer AJCC v7 | Stage I Lung Cancer AJCC v7 | Stage II Lung Cancer AJCC v7 | Stage IB Lung Cancer AJCC v7 | Stage IA Lung Cancer AJCC v7 | Stage IIA Lung Cancer AJCC v7 | Stage IIB Lung Cancer AJCC v7 | Stage IIIA Lung Cancer AJCC v7 | Stage IIIB Lung Cancer AJCC v7United States
-
Dana-Farber Cancer InstituteMedWaves, IncNot yet recruitingLung Cancer | Lung Cancer Stage I | Lung Cancer Stage II | Stage I Lung Cancer | Stage I - II Primary Lung Cancer | Stage II Lung CancerUnited States
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
Emory UniversityNational Cancer Institute (NCI)TerminatedLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
University of California, San FranciscoMerck Sharp & Dohme LLCWithdrawnLung Non-Small Cell Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage I Lung Cancer AJCC v8 | Stage IA1 Lung Cancer AJCC v8 | Stage IA2 Lung Cancer AJCC v8 | Stage IA3 Lung Cancer AJCC v8 | Stage IB Lung Cancer...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Metastatic Lung Carcinoma | Stage IV Lung Cancer AJCC v8 | Head and Neck Carcinoma | Lung Carcinoma | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung... and other conditionsUnited States
Clinical Trials on irinotecan hydrochloride
-
H. Lee Moffitt Cancer Center and Research InstituteTerminatedGlioma | Astrocytoma | OligodendrogliomaUnited States
-
University of ArizonaNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Japan Multinational Trial OrganizationCompleted
-
Luye Pharma Group Ltd.CompletedAdvanced Solid TumorChina
-
Fudan UniversityNot yet recruitingSmall Cell Lung Cancer RecurrentChina
-
Mayo ClinicNational Comprehensive Cancer NetworkCompletedStage III Gallbladder Cancer AJCC v8 | Stage IIIA Gallbladder Cancer AJCC v8 | Stage IIIB Gallbladder Cancer AJCC v8 | Refractory Gallbladder Carcinoma | Stage IV Gallbladder Cancer AJCC v8 | Stage IV Distal Bile Duct Cancer AJCC v8 | Stage IV Intrahepatic Bile Duct Cancer AJCC v8 | Stage IVB Gallbladder... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingErlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid TumorsAdult Solid NeoplasmUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedBreast CancerUnited States, Canada