search
Back to results

Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
celecoxib
paclitaxel
Placebo
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with biopsy proven non-small cell lung cancer clinical stage IIIA Mediastinoscopy positive N2 disease is mandatory The disease must be deemed potentially resectable by the thoracic surgeon Karnofsky performance status > 80% Pulmonary function must be acceptable for surgery according to institutional standards Acceptable hepatic, renal and bone marrow function Total serum bilirubin < ULN AST and/or ALT < 2.5x ULN Alkaline phosphatase < 2.5x ULN Serum creatinine < 2.0 mg/mm3 White blood cell > 3000/mm3 Platelets > 100,000/mm3 Age 18 or older Willingness to abstain from chronic use of NSAIDs (defined as > 7 days of continuous therapy per month OR defined as frequency of > 3 times per week) for the duration of the study. For those patients on NSAIDs prior to study entry, cessation of the drug for 72 hours prior to study entry is required Patients on low-dose ASA (<325 mg daily) for prophylaxis of cardiovascular disease prior to study entry may remain on that dose of ASA during this trial No anticipated chronic use of steroids. Patients may take the inhaled steroids mometasone or fluticasone if medically indicated Exclusion Criteria: Patients with known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates Hypersensitivity to paclitaxel Significant medical or psychiatric illness that would interfere with patient compliance Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer Receiving other investigational agents during the course of this study or are < 3 weeks from completion of other clinical trial therapy Patients with a history of peptic ulcer disease, bleed disorder, irritable bowel disease, inflammatory bowel syndrome, chronic diarrhea or bowel obstruction within 5 years Patients receiving enzyme-inducing anticonvulsants are ineligible. Patients who require concomitant therapy with NSAIDs or COX-2 inhibitors Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment Patients receiving lithium or fluconazole Pregnant women or women of childbearing potential that refuse to use effective contraception during the period of chemotherapy. Patients with a significant history of unstable cardiovascular disease Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • New York Weill Cornell Cancer Center at Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

paclitaxel/carboplatin/celecoxib

paclitaxel/Carboplatin/Placebo

Arm Description

Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy

Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy

Outcomes

Primary Outcome Measures

Rates of complete pathological response and/or minimal residual microscopic disease at 3 years

Secondary Outcome Measures

Clinical response at 3 years
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years
Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo

Full Information

First Posted
June 5, 2003
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Pharmacia
search

1. Study Identification

Unique Protocol Identification Number
NCT00062179
Brief Title
Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
Official Title
A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Pharmacia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy such as paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug, may stop the growth of tumor cells by stopping blood flow to the tumor, and/or may block the enzymes necessary for tumor cell growth. Giving combination chemotherapy with celecoxib before surgery may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving paclitaxel together with carboplatin followed by surgery works compared to giving paclitaxel together with carboplatin and celecoxib followed by surgery in treating patients with stage IIIA non-small cell lung cancer.
Detailed Description
OBJECTIVES: Compare the complete pathological response rate and/or minimal residual microscopic disease in patients with stage IIIA non-small cell lung cancer treated with preoperative paclitaxel and carboplatin with vs without celecoxib. Compare the clinical response rate in patients treated with these regimens. Compare chemotherapy-related toxicity in patients treated with these regimens. Compare the time to progression, disease-free survival, and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to use of aspirin for prior cardiovascular disease (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on days 1, 22, and 43. Patients also receive oral celecoxib twice daily beginning on day 1 and continuing until the morning of surgical resection. Arm II: Patients receive paclitaxel and carboplatin as in arm I and an oral placebo twice daily beginning on day 1 and continuing until the morning of surgical resection. In both arms, patients undergo surgical resection and complete mediastinal lymph node dissection within 3-6 weeks after completion of chemotherapy. Patients resume oral celecoxib or placebo twice daily within 28-42 days after surgery and continue until 3 years from the date of randomization in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 months. PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) 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
stage IIIA non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paclitaxel/carboplatin/celecoxib
Arm Type
Experimental
Arm Description
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Celecoxib: 400 mg po BID 3 cycles of paclitaxel and carboplatin 21 days apart celecoxib 3-7 days before first dose of chemotherapy
Arm Title
paclitaxel/Carboplatin/Placebo
Arm Type
Placebo Comparator
Arm Description
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion Carboplatin: dosed at an AUC of 6 by the Calvert Formula Placebo 3 cycles of paclitaxel and carboplatin 21 days apart Placebo 3-7 days before first dose of chemotherapy
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Description
Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo 3-7 days before first dose of chemotherapy
Primary Outcome Measure Information:
Title
Rates of complete pathological response and/or minimal residual microscopic disease at 3 years
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Clinical response at 3 years
Time Frame
3 years
Title
Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years
Time Frame
3 years
Title
Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with biopsy proven non-small cell lung cancer clinical stage IIIA Mediastinoscopy positive N2 disease is mandatory The disease must be deemed potentially resectable by the thoracic surgeon Karnofsky performance status > 80% Pulmonary function must be acceptable for surgery according to institutional standards Acceptable hepatic, renal and bone marrow function Total serum bilirubin < ULN AST and/or ALT < 2.5x ULN Alkaline phosphatase < 2.5x ULN Serum creatinine < 2.0 mg/mm3 White blood cell > 3000/mm3 Platelets > 100,000/mm3 Age 18 or older Willingness to abstain from chronic use of NSAIDs (defined as > 7 days of continuous therapy per month OR defined as frequency of > 3 times per week) for the duration of the study. For those patients on NSAIDs prior to study entry, cessation of the drug for 72 hours prior to study entry is required Patients on low-dose ASA (<325 mg daily) for prophylaxis of cardiovascular disease prior to study entry may remain on that dose of ASA during this trial No anticipated chronic use of steroids. Patients may take the inhaled steroids mometasone or fluticasone if medically indicated Exclusion Criteria: Patients with known hypersensitivity or allergic reactions to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates Hypersensitivity to paclitaxel Significant medical or psychiatric illness that would interfere with patient compliance Prior malignancy within the last 3 years with the exception of non-melanoma skin cancer Receiving other investigational agents during the course of this study or are < 3 weeks from completion of other clinical trial therapy Patients with a history of peptic ulcer disease, bleed disorder, irritable bowel disease, inflammatory bowel syndrome, chronic diarrhea or bowel obstruction within 5 years Patients receiving enzyme-inducing anticonvulsants are ineligible. Patients who require concomitant therapy with NSAIDs or COX-2 inhibitors Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment Patients receiving lithium or fluconazole Pregnant women or women of childbearing potential that refuse to use effective contraception during the period of chemotherapy. Patients with a significant history of unstable cardiovascular disease Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Rickard
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

We'll reach out to this number within 24 hrs