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

This is an interventional treatment trial for Lung Cancer focused on measuring 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 Read More

Eligibility Criteria:

• Cytologically or histologically confirmed "COX dependent" non-small cell lung cancer.
• COX dependency is defined by change in urinary PGE-M levels following a "run-in" phase of celecoxib.
• Previous treatment with ≤2 different chemotherapy regimens one of which must have been platinum-based (cisplatin or carboplatin) chemotherapy.
• Age ≥18 years
• ECOG PS 0, 1 or 2.
• Measurable or evaluable disease.
• At least 3 weeks post major surgery, chemotherapy or radiotherapy & recovered from all toxicities.
• Expected survival of at least 2 months.
• CNS metastases permitted provided the patient has adequately recovered from radiotherapy includes stereotactic therapy) or surgery.
• Adequate renal function: serum creatinine ≤1.8 mg/dl &/or CrCl >50 cc/min

Eligibility According to Liver Function:

AST:

</= 1.5 ULN-Docetaxel; </= 2.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed in the absence of proven or radiographically suspected liver metastases.); </= 5.0 ULN-Pemetrexed (Liver parameters to be used for pemetrexed only in the presence of proven or radiographically suspected liver metastases.)

Alk Phosphatase:

</= 2.5 ULN-Docetaxel; </= 2.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed in the absence of proven or radiographically suspected liver metastases.); </= 5.0 ULN-Pemetrexed (Liver parameters to be used for pemetrexed only in the presence of proven or radiographically suspected liver metastases.)

Total Bilirubin:

</= 1.5 ULN-Docetaxel; </= 1.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed in the absence of proven or radiographically suspected liver metastases.); </= 2.5 ULN-Pemetrexed (Liver parameters to be used for pemetrexed only in the presence of proven or radiographically suspected liver metastases.)

• Adequate hematologic function: ANC≥1500/mm3 & platelets ≥100,000/mm3
• Female patients cannot be pregnant and must use contraception if of childbearing age
• Lactating women are excluded.
• 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.

Exclusion Criteria:

• 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.