Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Celecoxib Plus Chemotherapy [Docetaxel or Pemetrexed] in Patients With Previously Treated, "COX Dependent" Recurrent Non-Small Cell Lung Cancer
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | October 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee |
United States | Vanderbilt-Ingram Cancer Center at Franklin | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect of Celecoxib on Urinary Metabolites of PGE2, PG12 and Thromboxane | At 1 year | No | |
Other | Changes in Urinary PGE-M and Survival as Assessed by Immunohistochemistry | At 1 year | No | |
Primary | 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 | No |
Secondary | Overall Response Rate | Overall response rate is measured by complete response + partial response. Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD. | On-treatment date to date of disease progression (assessed at 6 weeks up to 2 years) | No |
Secondary | Time to Progression | Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions. | 2 years from date of registration | No |
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