Clinical trial · Interventional
Celecoxib and Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
Evaluation Of Celecoxib In Combination With Docetaxel In The Treatment Of Advanced Non-Small Cell Lung Cancer Patients Previously Treated With Platinum Based Chemotherapy
NCT00030420CI-TRIAL-00010152completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining celecoxib and docetaxel in treating patients who have advanced non-small cell lung cancer that has been previously treated with platinum-based chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Celecoxib & Docetaxel
- description
- Celecoxib: 400mg by mouth, twice a day, each dose given with meals, to start -7 days prior to first cycle of treatment. Doctaxel: Day 1, 75mg/m2 IV over 60 minutes, repeated every 21 days
- interventionNames
- Drug: Celecoxib
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Efficacy of combining Celecoxib with Docetaxel
- timeFrame
- Weeks 1 , 2 and 3
- description
- Blood levels of VEGF \& PGE2
Secondary outcomes (5)
- measure
- Response rate of Celecoxib and Docetaxel
- timeFrame
- Every 2 cycles (or every 42 days); After therapy is completed or if the patient is only on Celecoxib, will be assessed for progression every month by clinical exam and every 3 months by radiological evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage IIIA, IIIB, or IV non-small cell lung cancer * Disease progression during or after 1 or more platinum-based chemotherapy regimens * Measurable or evaluable disease * No symptomatic or untreated brain or leptomeningeal metastases * Previously treated patients must be neurologically stable for 4 weeks after completion of appropriate therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8 g/dL Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST/ALT no greater than ULN (or no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN) * Alkaline phosphatase no greater than ULN (or no greater than 5 times ULN if AST/ALT no greater than ULN) * No history of chronic hepatitis of any duration Renal: * Creatinine no greater than ULN Cardiovascular: * No uncontrolled congestive heart failure * No uncontrolled angina * No myocardial infarction and/or stroke within the past 6 months * No active thromboembolic event within the past 4 weeks Gastrointestinal: * No gastrointestinal bleeding within the past 6 months * No history of peptic ulcer disease Other: * No prior hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No prior allergy to any non-steroidal anti-inflammatory drug * No other prior or concurrent malignancy within the past 3 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * No grade 2 or greater peripheral neuropathy * No active infection * No other serious concurrent medical illness * No history of dementia, active psychiatric disorder, or other condition that would interfere with ability to take oral medication or preclude compliance with study * HIV negative * Must weigh at least 50 kg (110 pounds) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * Prior paclitaxel allowed * No prior docetaxel Endocrine therapy: * At least 3 days since prior steroids Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to target lesion Surgery: * At least 4 weeks since prior major surgery Other: * Prior intermittent use of non-steroidal anti-inflammatory drugs (NSAIDs), including rofecoxib or celecoxib, allowed * At least 1 week since prior fluconazole * No recent prior NSAIDs, including rofecoxib or celecoxib, for a duration of more than 30 consecutive days * No concurrent fluconazole or lithium * No other concurrent NSAIDs except aspirin administered at a dose of no more than 325 mg/day for cardiovascular conditions * No other concurrent cyclo-oxygenase-2 inhibitors * No other concurrent investigational agents
References
Publications (1)
- RESULTSchneider BJ, Kalemkerian GP, Kraut MJ, Wozniak AJ, Worden FP, Smith DW, Chen W, Gadgeel SM. Phase II study of celecoxib and docetaxel in non-small cell lung cancer (NSCLC) patients with progression after platinum-based therapy. J Thorac Oncol. 2008 Dec;3(12):1454-9. doi: 10.1097/JTO.0b013e31818de1d2. PMID 19057272