NCT00062179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Mar 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

August 3, 2020

Status Verified

August 1, 2012

Enrollment Period

3.7 years

First QC Date

June 5, 2003

Last Update Submit

July 30, 2020

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (3)

  • Clinical response at 3 years

    3 years

  • Difference in time to progression, disease-free survival, and overall survival between Arm I and Arm II at 3 years

    3 years

  • Toxicity in patients with paclitaxel/carboplatin/celecoxib vs. paclitaxel/carboplatin/placebo

Study Arms (2)

paclitaxel/carboplatin/celecoxib

EXPERIMENTAL

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: carboplatinDrug: celecoxibDrug: paclitaxel

paclitaxel/Carboplatin/Placebo

PLACEBO COMPARATOR

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: carboplatinDrug: paclitaxelOther: Placebo

Interventions

carboplatinDRUG

Carboplatin: dosed at an AUC of 6 by the Calvert Formula 3 cycles of carboplatin 21 days apart

paclitaxel/Carboplatin/Placebopaclitaxel/carboplatin/celecoxib
celecoxibDRUG

Celecoxib: 400 mg po BID celecoxib 3-7 days before first dose of chemotherapy

paclitaxel/carboplatin/celecoxib
paclitaxelDRUG

Paclitaxel: 225 mg/m2 by 3-hour intravenous infusion 3 cycles of paclitaxel 21 days apart

paclitaxel/Carboplatin/Placebopaclitaxel/carboplatin/celecoxib
PlaceboOTHER

placebo 3-7 days before first dose of chemotherapy

paclitaxel/Carboplatin/Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinCelecoxibPaclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Karen Rickard

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

March 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

August 3, 2020

Record last verified: 2012-08

Locations

US(2)