Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: celecoxib Drug: cyclophosphamide Other: laboratory biomarker analysis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies |
- Toxicity [ Designated as safety issue: Yes ]
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Survival [ Designated as safety issue: No ]
- Time to failure [ Designated as safety issue: No ]
| Enrollment: | 57 |
| Study Start Date: | September 2001 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To describe the toxicities of oral cyclophosphamide when administered with escalating doses of celecoxib in patients with advanced malignancies.
- To evaluate the effects of this regimen on plasma levels of vascular endothelial growth factor.
OUTLINE: This is a dose-escalation study of celecoxib.
In the first course, patients receive oral cyclophosphamide once daily on days 1-35 and oral celecoxib twice daily on days 8-35. In all subsequent courses, patients receive oral cyclophosphamide once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, periodically during treatment, and at time of tumor progression. Samples are analyzed for vascular endothelial growth factor levels and stored for future analysis of circulating DNA of angiogenic biomarkers.
After completion of study therapy, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00551889 History of Changes |
| Other Study ID Numbers: | 00191, P30CA033572, CHNMC-00191, CDR0000570416 |
| Study First Received: | October 30, 2007 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by City of Hope Medical Center:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Cyclophosphamide Celecoxib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Myeloablative Agonists Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013