OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

Phase 3

Completed

• Conditions: Fallopian Tube Cancer; Peritoneal Neoplasms; Ovarian Cancer
• Interventions: Drug: carboplatin; Drug: phenoxodiol; Drug: placebo

• Registration Number: NCT00382811
• Lead Sponsor: MEI Pharma, Inc.

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, side-effects of treatment may result.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-28
• Study First Submitted QC: 2006-09-28
• Study Start: 2006-10
• Study First Posted: 2006-10-02
• Primary Completion: 2009-04
• Study Completion: 2011-04
• Status Verified: 2016-07
• Disposition First Submitted: 2016-07-12
• Disposition First Submitted QC: 2016-07-12
• Last Update Submitted: 2016-07-13
• Disposition First Posted: 2016-07-14
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	carboplatin	Daily phenoxodiol placebo + weekly carboplatin
2	placebo	Daily phenoxodiol placebo + weekly carboplatin
1	carboplatin	Daily Phenoxodiol + weekly carboplatin
1	phenoxodiol	Daily Phenoxodiol + weekly carboplatin

Primary Outcome Measures

Name	Time	Method
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death	Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy end-point is overall survival (OS)	Overall survival

Trial Locations

Locations (70)

Arizona Clinical Research Center, Inc.; 🇺🇸 Tuscon, Arizona, United States

Glendale Adventist; 🇺🇸 Glendale, California, United States

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Gynecology Oncology Associates; 🇺🇸 Newport Beach, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center); 🇺🇸 Stamford, Connecticut, United States

Gynecologic Oncology Associates; 🇺🇸 Pembroke Pines, Florida, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Medical College of Georgia Cancer Center; 🇺🇸 Augusta, Georgia, United States

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