Clinical trial · Interventional
Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer
Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies
- 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: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may help kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with cyclophosphamide in treating patients with advanced cancer.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Toxicity
- measure
- Maximum tolerated dose
- measure
- Survival
- measure
- Time to failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven diagnosis of a malignant disease for which no satisfactory treatment exists at the time of enrollment * Patients with brain metastases that, at the time of study enrollment, are controlled and do not require treatment with corticosteroids are eligible PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy ≥ 3 months * ANC \> 1.5 x 10\^9/L * Platelet count \> 100 x 10\^9/L * Creatinine clearance \> 50 mL/min * Serum bilirubin \< 1.5 mg/dL * AST or ALT \< 2.0 times upper limit of normal (unless clearly due to the presence of tumor) * Not pregnant or nursing * Fertile patients must use effective contraception * Patient must be capable of understanding the nature of the trial and must give written informed consent * No unstable or severe intercurrent medical conditions or active, uncontrolled infection * No history of allergic reactions to nonsteroidal anti-inflammatory drugs * No bleeding peptic ulcer within the past 3 months * No allergy to sulfa drugs PRIOR CONCURRENT THERAPY: * Recovered from all prior therapy * No radiotherapy or chemotherapy within the 3 weeks (nitrosoureas or mitomycin C within 6 weeks) prior to anticipated first day of dosing * No concurrent therapy with other investigational agents or antineoplastic therapy
References
Publications (0)
Data not yet available