Clinical Trial VICCTHO0730
A Phase II Trial of Celecoxib plus Chemotherapy [Docetaxel or Pemetrexed] in Patients with Previously Treated, "COX Dependent" Recurrent Non-Small Cell Lung Cancer (SPORE)
- Protocol No. VICCTHO0730
- Open Date: 10/15/2007
- Staging: Phase II
- Age Group: Adults
- Scope: Local
- Objective: To determine the efficacy of a selective COX-2 inhibitor [celecoxib] plus standard chemotherapy [docetaxel or pemetrexed] in patients with recurrent NSCLC exhibiting "COX dependence". COX dependency to be determined by measuring urinary PGE-M levels pre- and post-celecoxib as a surrogate of systemic PGE2 levels. The trial is designed to identify a 50% increase in median survival compared with historical control data.
- Disease Sites: Lung; Non Small Cell
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Alimta; Celecoxib; Docetaxel; Docetaxel (Taxotere); Pemetrexed
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT00520845
- Secondary Protocol No: Not Specified
This research is being done because there is a need for more effective treatment for lung cancer patients whose tumors have progressed following treatment with chemotherapy. Patients are being asked to take part in this research study because they have lung cancer and it has progressed after treatment with chemotherapy. Patients have the option of being treated with docetaxel alone, pemetrexed alone or other types of chemotherapy. This study will combine docetaxel or pemetrexed with celecoxib. Docetaxel and pemetrexed are FDA-approved for treating lung cancer that has progressed following treatment with chemotherapy. Celecoxib is FDA approved for treatment of arthritis. The use of these drugs in combination is considered experimental.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
• 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:
</= 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.)
</= 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.)
</= 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.
• 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.