Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00551889
Cyclophosphamide and Celecoxib in Treating Patients With Advanced Cancer
A Phase 1 study testing celecoxib, cyclophosphamide and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- celecoxib, cyclophosphamide and laboratory biomarker analysis
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies
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.
Read the 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.
- Being tested
- celecoxib, cyclophosphamide, laboratory biomarker analysis
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
cyclophosphamideDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Maximum tolerated dose
Survival
Time to failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startSep 2001
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Przemyslaw W. Twardowski, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551889
- Sponsor's protocol ID
- 00191
- Other IDs
- P30CA033572, CHNMC-00191, CDR0000570416
- Status last verified
- Nov 2012
- First submitted
- 30 Oct 2007
- Last updated
- 12 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Oral Cyclophosphamide in Combination With Celecoxib in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00551889
- Acronym / sponsor ID
- 00191
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2001
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib | Drug | – |
| cyclophosphamide | Drug | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Toxicity
Maximum tolerated dose
Survival
Time to failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Przemyslaw W. Twardowski, MD study chair
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing celecoxib, cyclophosphamide and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.