Paclitaxel and Carboplatin With or Without Celecoxib Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborators:
Pharmacia
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00062179
First received: June 5, 2003
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: celecoxib Drug: paclitaxel Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized Double Blind Phase II Study of Preoperative Celecoxib/Paclitaxel/Carboplatin for Stage IIIA Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- Rates of complete pathological response and/or minimal residual microscopic disease at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical response at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo [ Designated as safety issue: Yes ]
| Enrollment: | 7 |
| Study Start Date: | March 2003 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: paclitaxel/carboplatin/celecoxib
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
|
Drug: carboplatin
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Drug: celecoxib
Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy
Drug: paclitaxel
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
|
|
Placebo Comparator: paclitaxel/Carboplatin/Placebo
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
|
Drug: carboplatin
Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart
Drug: paclitaxel
Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart
Other: Placebo
placebo 3-7 days before first dose of chemotherapy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062179
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| United States, New York | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Pharmacia
Investigators
| Principal Investigator: | Karen Rickard | Beckman Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00062179 History of Changes |
| Other Study ID Numbers: | CDR0000304540, P30CA016042, UCLA-0208074, NYH-CMC-0902-464, PHARMACIA-COXAON-0509-106 |
| Study First Received: | June 5, 2003 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
stage IIIA non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carboplatin Paclitaxel Celecoxib Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 13, 2013