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

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib; Docetaxel; Pemetrexed

Criteria

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:

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

Alk Phosphatase:

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

Total Bilirubin:

in the absence of proven or radiographically suspected liver metastases.);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.