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

July 10, 2012 updated by: Northwestern University

Phase I/II Trial Of Weekly Irinotecan And Docetaxel With The Addition Of Celecoxib In Advanced Non-Small Cell Lung Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Evanston, Illinois, United States, 60201
        • Evanston Northwestern Health Care - Evanston Hospital
      • Joliet, Illinois, United States, 60432
        • Silver Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Athanassios Argiris, MD, Robert H. Lurie Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

December 10, 2003

First Submitted That Met QC Criteria

December 10, 2003

First Posted (Estimate)

December 11, 2003

Study Record Updates

Last Update Posted (Estimate)

July 19, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 01L2
  • NU-01L2
  • PHARMACIA-NU-01L2

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.

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