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

Brief Title

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

Official Title

Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol in Combination With Carboplatin Versus Carboplatin With Placebo in Patients With Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death

Secondary Outcome

 The secondary efficacy end-point is overall survival (OS)

Condition

Fallopian Tube Cancer

Intervention

phenoxodiol

Study Arms / Comparison Groups

Description:  Daily Phenoxodiol + weekly carboplatin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

October 2006

Completion Date

April 2011

Primary Completion Date

April 2009

Eligibility Criteria

        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.

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Daniel P Gold, PhD, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT00382811

Organization ID

NV06-0039

Responsible Party

Sponsor

Study Sponsor

MEI Pharma, Inc.

Study Sponsor

Daniel P Gold, PhD, Study Director, MEI Pharma, Inc.

Verification Date

July 2016