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Cyclophosphamide With or Without Celecoxib in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Randomized Pilot Trial of Oral Cyclophosphamide Versus Oral Cyclophosphamide With Celecoxib for Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00538031
Enrollment
52
Registered
2007-10-02
Start date
2003-12-22
Completion date
2019-09-13
Last updated
2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Brief summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide together with celecoxib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide together with celecoxib works compared to cyclophosphamide alone in treating patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed description

OBJECTIVES: I. To assess the response rates in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who are treated with oral cyclophosphamide alone or oral cyclophosphamide with celecoxib. II. To assess the time to disease progression in this group of patients. III. To further describe the toxicities of oral cyclophosphamide with or without celecoxib in the above patient population. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral cyclophosphamide once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oral cyclophosphamide once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.

Interventions

DRUGcyclophosphamide

Given orally

DRUGcelecoxib

Given orally

Sponsors

City of Hope Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion * Patients with recurrent or residual epithelial ovarian, Fallopian tube, or primary papillary peritoneal cancer, which has been histologically confirmed regardless of prior treatment * Patients with measurable disease or rising CA-125 to levels at least twice normal (the CA-125 increase must be documented by two independent measurements at least 4 weeks apart) * Patient must have adequate renal function documented by a creatinine \< 1.5 * Patients must have adequate bone marrow function as evidenced by an absolute neutrophil count of \> 1.5 x 10\^9/L and a platelet count \> 100 x 10\^9/L * Patients must have a Karnofsky performance status of 60-100% * Patient must be capable of understanding the nature of the trial and must give written informed consent * Patients must have life expectancy of at least three months * Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible Exclusion * Patients who have had radiotherapy or chemotherapy within three weeks prior to anticipated first day of dosing (patients must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy * Patient with unstable or severe intercurrent medical conditions or active, uncontrolled infection * Patients with history of bleeding peptic ulcer within last 3 months * Patients undergoing therapy with other investigational agents (patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study * Patients who are allergic to sulfa drugs * Pregnant women will be excluded from this study due to the potential of harm to the fetus * Patients with clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction unstable angina), New York heart association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to study entry * Subjects with hypertension are eligible if their blood pressure as been normal while on a stable dose of medication for at least one year

Design outcomes

Primary

MeasureTime frameDescription
Overall ResponseUp to 3 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time to Treatment FailureUp to 3 yearsEstimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Overall SurvivalUp to 5 yearsEstimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm I (Cyclophosphamide Alone)
Patients receive 50 mg oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
26
Arm II (Cyclophosphamide + Celecoxib)
Patients receive 50 mg oral cyclophosphamide once daily and 400 mg oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
26
Total52

Baseline characteristics

CharacteristicArm I (Cyclophosphamide Alone)Arm II (Cyclophosphamide + Celecoxib)Total
Age, Continuous60 years61 years61 years
Karnofsky performance status90 units on a scale90 units on a scale90 units on a scale
Race/Ethnicity, Customized
Asian
4 Participants5 Participants9 Participants
Race/Ethnicity, Customized
Hispanic
1 Participants5 Participants6 Participants
Race/Ethnicity, Customized
Native American
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Unknown
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White non-Hispanic
20 Participants15 Participants35 Participants
Region of Enrollment
United States
26 participants26 participants52 participants
Sex: Female, Male
Female
26 Participants26 Participants52 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
26 / 2626 / 26
other
Total, other adverse events
26 / 2626 / 26
serious
Total, serious adverse events
4 / 268 / 26

Outcome results

Primary

Overall Response

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Time frame: Up to 3 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm I (Cyclophosphamide Alone)Overall Response1 Participants
Arm II (Cyclophosphamide + Celecoxib)Overall Response1 Participants
Primary

Overall Survival

Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment to death from any cause.

Time frame: Up to 5 years

ArmMeasureValue (MEDIAN)
Arm I (Cyclophosphamide Alone)Overall Survival9.69 Months
Arm II (Cyclophosphamide + Celecoxib)Overall Survival12.55 Months
p-value: 0.95Log Rank
Primary

Time to Treatment Failure

Estimated using the product-limit method of Kaplan and Meier. Time to treatment failure is defined as the time from initial treatment to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: Up to 3 years

ArmMeasureValue (MEDIAN)
Arm I (Cyclophosphamide Alone)Time to Treatment Failure1.84 Months
Arm II (Cyclophosphamide + Celecoxib)Time to Treatment Failure1.92 Months
p-value: 0.61Log Rank

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026