Status:
COMPLETED
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Lead Sponsor:
MEI Pharma, Inc.
Conditions:
Fallopian Tube Cancer
Peritoneal Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in combination with weekly carboplatin, is effective against late stage ovarian cancer and to see what, if any, si...
Eligibility Criteria
Inclusion
- Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin
- Recurrent or persistent advanced disease
- Have measurable disease
- Undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy as determined by either Response Evaluation Criteria in Solid Tumors (RECIST) or Gynecologic Cancer Intergroup (GCIG) criteria
- Disease relapse as determined by either RECIST or GCIG criteria within 6 months of completion of the second or greater course of platinum therapy using a 2-, 3- or 4-weekly regimen and platinum-free interval of no greater than 6 months at the time of enrollment, being the time taken from the last day of platinum therapy
- Any number of previous courses of platinum therapy or non-platinum therapy
- Likely to survive at least 3 months
- Karnofsky performance score of at least 60%
- Have adequate physiological function without evidence of major organ dysfunction as evidenced by:
- serum creatinine \< 1.5 mg/dl
- serum transaminase levels ≤ 3 x the upper limit of normal (ULN) for the reference laboratory and
- bilirubin level \< ULN
- Have adequate hematological function defined by:
- platelets \> 100,000/mm3
- white cell counts (WCC) \> 3,000/mm3
- neutrophils \> 1,500/mm3
- hemoglobin \> 8.0 g/dl
- Aged \> 18
- Be able to understand the risks and benefits of the study and give written informed consent to participation.
Exclusion
- Patients with mucinous histological type of ovarian cancer
- Patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy
- Patients with active infection
- Patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.)
- Patients with a history of chronic active hepatitis or cirrhosis
- Patients with HIV
- Patients with active central nervous system (CNS) metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks.
- Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy
- Patients with known hypersensitivity to platinum drugs that cannot be managed with concomitant medication.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00382811
Start Date
October 1 2006
End Date
April 1 2011
Last Update
July 18 2016
Active Locations (70)
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1
Arizona Clinical Research Center, Inc.
Tuscon, Arizona, United States, 85715
2
Glendale Adventist
Glendale, California, United States, 91206
3
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048