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

NCT00520845 | Terminated Phase 2 Results DMC

• 4 other identifiers: VICC THO 0730P30CA068485VU-VICC-THO-0730VU-VICC-IRB-070723
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Median Survival

  Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)

  2 years from date of registration

Secondary Outcomes (2)

• Overall Response Rate

  On-treatment date to date of disease progression (assessed at 6 weeks up to 2 years)

• Time to Progression

  2 years from date of registration

Other Outcomes (2)

• Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane

  At 1 year

• Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry

  At 1 year

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Either docetaxel or pemetrexed given with celecoxib

Drug: celecoxib; Drug: Docetaxel; Drug: pemetrexed disodium; Other: laboratory biomarker analysis

Interventions

celecoxib 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.

Treatment Arm

Docetaxel DRUG

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

Treatment Arm

pemetrexed disodium DRUG

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

Treatment Arm

laboratory biomarker analysis OTHER

Blood collection

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clnical Trial

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib; Docetaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Dr. Leora Horn
• Organization: Vanderbilt-Ingram Cancer Center

leora.horn@vanderbilt.edu

615-322-4967

Study Officials

• Leora Horn, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist

Study Record Dates

• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 20, 2017
• Results First Posted: October 9, 2014

Record last verified: 2017-02

Locations

US (3)