Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung Cancer

NCT ID: NCT00520845

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2014-01-31

Brief Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with docetaxel or pemetrexed may kill more tumor cells.

PURPOSE: This phase II trial is studying how well celecoxib given together with docetaxel or pemetrexed works in treating patients with advanced or recurrent non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

• To determine the efficacy of celecoxib when administered with standard chemotherapy comprising docetaxel or pemetrexed disodium in patients with advanced, recurrent non-small cell lung cancer (NSCLC) exhibiting cyclooxygenase (COX) dependence.

Secondary

• To determine the overall response rate and time to progression in patients with COX-dependent recurrent NSCLC treated with celecoxib and docetaxel or pemetrexed disodium.
• To determine the effect of celecoxib on the urinary metabolites of PGE_2 , PGI_2, and thromboxane in patients with COX-dependent recurrent NSCLC.
• To correlate changes in urinary PGE-M and survival with intratumoral expression of COX-2, mPGES, and 15-PGDH as assessed by IHC.

OUTLINE: Patients with no prior taxane exposure receive docetaxel IV over 1 hour on day 1; patients with prior taxane exposure or for whom docetaxel treatment is contraindicated receive pemetrexed disodium IV over 10 minutes on day 1. Treatment with docetaxel or pemetrexed disodium repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral celecoxib twice daily beginning 5-7 days prior to the first docetaxel or pemetrexed disodium infusion and continuing for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients undergo blood and urine sample collection at baseline and periodically during study for biomarker correlative studies. Urine samples are assessed for PGE-M levels. Blood samples are analyzed for serum celecoxib levels, VEGF, endostatin, and cytokine assays.

After completing the last dose of celecoxib, patients are followed at 4-6 weeks and then every 3 months thereafter for up to 2 years from study entry.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Either docetaxel or pemetrexed given with celecoxib

Group Type: EXPERIMENTAL

celecoxib

Intervention Type: DRUG

600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Docetaxel

Intervention Type: DRUG

75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

pemetrexed disodium

Intervention Type: DRUG

500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

laboratory biomarker analysis

Intervention Type: OTHER

Blood collection

Interventions

celecoxib

600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.

Intervention Type: DRUG

Docetaxel

75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle

Intervention Type: DRUG

pemetrexed disodium

500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.

Intervention Type: DRUG

laboratory biomarker analysis

Blood collection

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

• Peripheral neuropathy must be CTC grade ≤2
• Patients must not currently be on non-steroidal anti-inflammatory agents or other COX-2 inhibitors (Must be off for at least ≤7 days)
• Written informed consent.

• More than two prior chemotherapy regimens for recurrent or relapsed NSCLC.
• COX Independent as defined by change in urinary PGE-M levels following a "run-in" phase of celecoxib.
• Previous treatment with both docetaxel and pemetrexed
• History of greater than grade 2 allergic reaction to celecoxib or any other non-steroid anti-inflammatory agent including aspirin, ibuprofen, or indomethacin.
• History of allergy to compounds containing boron or mannitol.
• History of allergy to sulfonamides.
• Concomitant use of Warfarin, but low dose Coumadin allowed for port prophylaxis
• Recent (past 4 weeks) coronary artery bypass graft (CABG) surgery.
• Inadequate organ function:
• Serum creatinine ≥1.8 mg/dl or a calculated CrCl <45 cc/min.
• AST >1.5 upper limits of normal (ULN); alkaline phosphatase >2.5 ULN; & bilirubin >1.5 ULN
• ANC<1500/mm3 & platelets <100,000/mm3
• Active pregnancy or inability or unwillingness to employ appropriate contraception.
• Small cell carcinoma histology.
• Prior malignancy within 5 years of diagnosis of NSCLC. Exceptions include basal cell or non-metastatic squamous cell carcinomas of the skin, cervical carcinoma in situ or FIGO stage I cervical carcinoma, or other cancer history considered not clinically significant by the principal investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Leora Horn, MD

Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leora Horn, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Related Links

http://www.vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clnical Trial

Other Identifiers

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-THO-0730

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-070723

Identifier Type: -

Identifier Source: secondary_id

VICC THO 0730

Identifier Type: -

Identifier Source: org_study_id