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Status:

COMPLETED

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

Lead Sponsor:

Northwestern University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

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...

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 ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    December 1 2004

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00073866

    Start Date

    June 1 2003

    End Date

    December 1 2004

    Last Update

    July 19 2012

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, United States, 60611-3013

    2

    Evanston Northwestern Health Care - Evanston Hospital

    Evanston, Illinois, United States, 60201

    3

    Silver Cross Hospital

    Joliet, Illinois, United States, 60432

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