Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00551889
First received: October 30, 2007
Last updated: November 8, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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)
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551889

Sponsors and Collaborators
City of Hope Medical Center
Investigators
Study Chair: Przemyslaw W. Twardowski, MD Beckman Research Institute
  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:
Celecoxib
Cyclophosphamide
Alkylating Agents
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014