Sponsored by Vanderbilt-Ingram Cancer Center

Phase	Quota	Distance
Phase 2		Near

RATIONALE: Celecoxib and pemetrexed 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 recurrent non-small cell lung cancer.

Study Start Date: October 2007

Estimated Completion Date: December 2019

Specialties: Pulmonology: Clinical Pharmacology,Lung/Thoracic Oncology Oncology: Lung/Thoracic Oncology,Pharmacology/Therapy Pharmacy: Chemotherapy/Oncology

Interventions

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

Inclusion criteria

• DISEASE CHARACTERISTICS:
• Cytologically or histologically confirmed non-small cell lung cancer
• No small cell carcinoma histology
• Measurable or evaluable disease
• Advanced, recurrent, or relapsed disease
• Must have received at least 1, but no more than 2, prior chemotherapy regimens including one platinum-based (i.e., cisplatin or carboplatin) regimen
• Cyclooxygenase (COX)-dependent disease, as demonstrated by a >= 70% decrease in urinary PGE-M level after exposure to celecoxib
• Must have received <= 2 chemotherapy regimens 1 of which must have been a platinum-based regimen (cisplatin or carboplatin)
• CNS metastases allowed provided the patient has adequately recovered from radiotherapy (including stereotactic therapy) or surgey
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Life expectancy >= 2 months
• Serum creatinine <= 1.8 mg/dL AND/OR creatinine clearance > 50 mL/min
• AST <= 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase <= 2.5 times ULN
• Bilirubin <= 1.5 times ULN
• ANC >= 1,500/mm³
• Platelet count >= 100,000/mm³
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Peripheral neuropathy <= grade 2
• PRIOR CONCURRENT THERAPY:
• At least 3 weeks since prior major surgery, chemotherapy, or radiotherapy and recovered
• At least 7 days since prior and no concurrent nonsteroidal anti-inflammatory agents or other COX-2 inhibitors
• More than 4 weeks since prior coronary artery bypass graft surgery

Exclusion criteria

• PATIENT CHARACTERISTICS:
• History of grade 2 allergy to celecoxib or any other nonsteroid anti-inflammatory agent including aspirin, ibuprofen, or indomethacin
• History of allergy to compounds containing boron or mannitol
• History of allergy to sulfonamides
• Other malignancy within 5 years of diagnosis of NSCLC, except basal cell or nonmetastatic squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or FIGO stage I cervical carcinoma
• PRIOR CONCURRENT THERAPY:
• Prior treatment with both docetaxel and pemetrexed disodium
• Concurrent warfarin
• Low-dose coumadin for port prophylaxis allowed
• Concurrent prophylactic filgrastim (G-CSF)
  
  

 

Study Locations And Contact Information

• Vanderbilt-Ingram Cancer Center at Franklin, Nashville Tennessee
  Contact: VICC Clinical Trials Information Program 800-811-8480
• Vanderbilt-Ingram Cancer Center, Nashville Tennessee
  Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480
• Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville Tennessee
  Contact: VICC Clinical Trials Information Program 800-811-8480