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Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
docetaxel
irinotecan hydrochloride
Sponsored by
Northwestern University
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 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: Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: Stage IV Stage IIIB with a malignant pleural effusion Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy Unidimensionally measurable disease If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area No CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal) Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal) Renal Creatinine less than 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80 No pre-existing grade 2 or greater peripheral neuropathy No concurrent medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy At least 1 week since prior biologic therapy Phase I patients: Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors) Phase II patients: No prior biologic therapy for recurrent/metastatic disease No concurrent filgrastim (G-CSF) Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy No prior irinotecan or docetaxel Phase I patients: Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible) Phase II patients: At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease No prior chemotherapy for recurrent/metastatic disease Endocrine therapy Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months Radiotherapy See Disease Characteristics Recovered from prior radiotherapy At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease Surgery Recovered from prior surgery Other More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole No concurrent NSAIDs No other concurrent COX-2 inhibitors

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Evanston Northwestern Health Care - Evanston Hospital
  • Silver Cross Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 2003
Last Updated
July 10, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00073866
Brief Title
Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title
Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

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. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Combining celecoxib with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of irinotecan and docetaxel when given together with celecoxib and to see how well they work in treating patients with advanced non-small cell lung cancer.
Detailed Description
OBJECTIVES: Determine the recommended phase II dose of docetaxel and irinotecan in combination with celecoxib in patients with advanced non-small cell lung cancer. Determine the toxic effects of this regimen in these patients. Determine the response rate of patients treated with this regimen. Determine the progression-free and overall survival of patients treated with this regimen. Determine the pharmacokinetics of this regimen in these patients. Correlate angiogenesis markers (intratumoral microvessel density and vascular endothelial growth factor [VEGF] expression and serum VEGF) and cyclooxygenase-2 expression with response and survival in patients treated with this regimen. Correlate UGT1A1 genotype and CYP3A4 activity with the toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study of docetaxel and irinotecan. Phase I: Patients receive docetaxel IV over 60 minutes and irinotecan IV over 30 minutes on days 1 and 8. Patients also receive oral celecoxib twice daily beginning on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of docetaxel and irinotecan until the recommended phase II dose is determined. The recommended phase II dose is defined as the highest dose at which 0 of 3 or 1 of 6 patients experience dose-limiting toxicity. Phase II: Patients receive treatment as in phase I at the recommended phase II dose. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 3-70 patients (3-36 for phase I and 16-34 for phase II) will be accrued for this study.

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 IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria: Stage IV Stage IIIB with a malignant pleural effusion Locally recurrent and/or persistent disease after locoregional therapy with or without systemic chemotherapy Unidimensionally measurable disease If the only site of measurable disease is in a previously irradiated area must have documented progression of disease in that area No CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST and ALT less than 2.5 times upper limit of normal (ULN) (if alkaline phosphatase is normal) Alkaline phosphatase less than 4 times ULN (if AST and ALT are normal) Renal Creatinine less than 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study treatment No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days No prior hypersensitivity to cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, sulfonamides, or drugs formulated with polysorbate 80 No pre-existing grade 2 or greater peripheral neuropathy No concurrent medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy At least 1 week since prior biologic therapy Phase I patients: Any number of prior biologic therapies allowed (e.g., chimeric antibodies or kinase inhibitors) Phase II patients: No prior biologic therapy for recurrent/metastatic disease No concurrent filgrastim (G-CSF) Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy No prior irinotecan or docetaxel Phase I patients: Up to 2 prior chemotherapy regimens for recurrent/metastatic disease allowed (chemonaïve patients are also eligible) Phase II patients: At least 1 year since prior adjuvant or neoadjuvant chemotherapy for stage I-IIIA disease No prior chemotherapy for recurrent/metastatic disease Endocrine therapy Less than 2 weeks of cumulative oral/IV corticosteroid use within the past 3 months Radiotherapy See Disease Characteristics Recovered from prior radiotherapy At least 3 weeks since prior extensive-field radiotherapy for recurrent/metastatic disease Surgery Recovered from prior surgery Other More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis No prior NSAIDs at a frequency of more than 3 times per week for a cumulative period of more than 2 weeks within the past 30 days No concurrent antiepileptics, cyclosporine, aspirin, or fluconazole No concurrent NSAIDs No other concurrent COX-2 inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanassios Argiris, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Evanston Northwestern Health Care - Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Silver Cross Hospital
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60432
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16096702
Citation
Argiris A, Kut V, Luong L, Avram MJ. Phase I and pharmacokinetic study of docetaxel, irinotecan, and celecoxib in patients with advanced non-small cell lung cancer. Invest New Drugs. 2006 May;24(3):203-12. doi: 10.1007/s10637-005-3259-4.
Results Reference
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Combination Chemotherapy and Celecoxib in Treating Patients With Advanced Non-Small Cell Lung Cancer

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