Phase 2
Completed N=21
Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00046839 ↗Enrolled (actual)
21
Serious AEs
11.1%
Results posted
Mar 2014
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT) — 0; 1 units on a scale
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT) |
0; 1 | — |
| PRIMARY Overall Survival |
10.0 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer
- Inoperable stage IIB OR
- Unresectable stage IIIA or IIIB
- No evidence of hematogenous metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 2 AND more than 5% weight loss over the past 3 months OR
- Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2 times upper limit of normal
- International Normalized Ratio (INR) no greater than 3.0 if taking warfarin
Renal
- Creatinine clearance at least 50 mL/min
Other
- No active gastrointestinal ulcers or bleeding within the past 3 months
- No other malignancy within the past 3 years except nonmelanoma skin cancer
- No known hypersensitivity to celecoxib
- No prior allergic-type reactions to sulfonamides
- No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior neoadjuvant chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- No prior thoracic radiotherapy
Surgery
- No prior complete or subtotal tumor resection
Other
- No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors
- Concurrent aspirin (325 mg/day) for cardioprotection allowed
Data sourced from ClinicalTrials.gov (NCT00046839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.