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Alkylating agents

cyclophosphamide for Ovarian Cancer

Phase 2
Waitlist Available
Led By Vincent Chung
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inclusion
Patients with recurrent or residual epithelial ovarian, Fallopian tube, or primary papillary peritoneal cancer, which has been histologically confirmed regardless of prior treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying the combination of cyclophosphamide and celecoxib to see how well it works compared to cyclophosphamide alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned or does not respond to treatment.

Eligible Conditions
  • Ovarian Cancer
  • Peritoneal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response
Overall Survival
Time to Treatment Failure

Side effects data

From 2016 Phase 2 trial • 303 Patients • NCT02004262
82%
Vaccination site erythema
63%
Chills
56%
Vaccination site induration
56%
Vaccination site pain
54%
Vaccination site oedema
54%
Pyrexia
53%
Fatigue
52%
Vaccination site pruritus
45%
Nausea
34%
Vomiting
32%
Abdominal pain
27%
Constipation
27%
Vaccination site bruising
26%
Decreased appetite
20%
Anaemia
19%
Hypotension
19%
Blood alkaline phosphatase increased
19%
Back pain
19%
Headache
18%
Aspartate aminotransferase increased
16%
Oedema peripheral
14%
Disease progression
14%
Hyponatraemia
14%
Tachycardia
13%
Diarrhoea
13%
Alanine aminotransferase increased
13%
Thrombocytopenia
12%
Pruritus
11%
Weight decreased
11%
Hypertension
10%
Abdominal distension
10%
Insomnia
9%
Ascites
9%
Erythema
9%
Abdominal pain upper
9%
Dehydration
9%
Hypoalbuminaemia
9%
Flatulence
9%
Blood bilirubin increased
9%
Dyspnoea
9%
Pain
7%
Dizziness
7%
Hypokalaemia
7%
Lymphocyte count decreased
7%
Myalgia
6%
Gastrooesophageal reflux disease
6%
Hypomagnesaemia
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Blood creatinine increased
6%
Pain in extremity
6%
Arthralgia
6%
Pulmonary embolism
6%
Hypoxia
6%
Vaccination site vesicles
5%
Hypophosphataemia
5%
Asthenia
5%
Blood albumin decreased
5%
Blood sodium decreased
5%
International normalised ratio increased
5%
Leukocytosis
5%
Deep vein thrombosis
5%
Night sweats
5%
Confusional state
5%
Bile duct obstruction
4%
Abdominal Pain
3%
Dry mouth
3%
Neuropathy peripheral
3%
Dry skin
3%
Sinus tachycardia
3%
Urinary tract infection
3%
Upper respiratory tract infection
2%
Upper gastrointestinal haemorrhage
2%
Cholangitis
2%
Cerebrovascular accident
2%
Cough
2%
Anxiety
2%
Malignant pleural effusion
1%
Neutropenia
1%
Hyperbilirubinaemia
1%
Failure to thrive
1%
Myocardial infarction
1%
Memory impairment
1%
Spinal cord compression
1%
Rash
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Gastritis
1%
Lower gastrointestinal haemorrhage
1%
Device dislocation
1%
Jaundice cholestatic
1%
Pneumonia
1%
Sepsis
1%
Herpes zoster
1%
Klebsiella sepsis
1%
Syncope
1%
Cerebral haemorrhage
1%
Transient ischaemic attack
1%
Haemorrhage
1%
Superior vena cava syndrome
1%
Atrial fibrillation
1%
Acute myocardial infarction
1%
Mental status changes
1%
Hallucination
1%
Gastrointestinal anastomotic complication
1%
Musculoskeletal chest pain
1%
Renal failure acute
1%
Small intestinal obstruction
1%
Death
1%
Hip fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pooled Cohort: Cy/GVAX + CRS-207
Pooled Cohort: CRS-207
Pooled Cohort: Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm IIExperimental Treatment2 Interventions
Patients receive oral cyclophosphamide once daily and oral celecoxib twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm IActive Control1 Intervention
Patients receive oral cyclophosphamide once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cyclophosphamide
1994
Completed Phase 3
~8140
celecoxib
2003
Completed Phase 3
~3010

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,399 Total Patients Enrolled
7 Trials studying Ovarian Cancer
217 Patients Enrolled for Ovarian Cancer
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
9 Previous Clinical Trials
357 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments is cyclophosphamide commonly prescribed to treat?

"Cyclophosphamide is an effective therapeutic agent for multiple sclerosis, leukemia, myelocytic disorders, acute illnesses and retinoblastoma."

Answered by AI

What other investigations have been conducted into the efficacy of cyclophosphamide?

"Currently, 851 clinical trials are underway researching the potential of cyclophosphamide. Of these investigations, 160 have moved into Phase 3. The vast majority of studies for this medication take place in Philadelphia, however there are 28,958 research sites conducting tests on its efficacy."

Answered by AI

Are there still opportunities to join this research endeavor?

"Unfortunately, this investigation is not currently recruiting subjects. The study began on December 22nd 2003 and was last updated March 17th 2022; if you are looking for other opportunities there are presently 1435 trials seeking participants with peritoneal cavity cancer and 851 studies accepting patients treated with cyclophosphamide."

Answered by AI

How many participants have enrolled in this research project?

"The enrollment period for this trial has since expired, as the last update was posted on March 17th 2022. However, there are currently 1435 studies recruiting patients with peritoneal cavity cancer and 851 clinical trials looking for participants who have been treated with cyclophosphamide."

Answered by AI

Is cyclophosphamide authorized by the FDA?

"Cyclophosphamide has been assigned a safety rating of 2 on the Power scale, as there is evidence to suggest that it is safe but no studies have yet established its efficacy."

Answered by AI
~2 spots leftby Mar 2025