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

MEI Pharma

Status and phase

Completed

Phase 3

Conditions

Peritoneal Neoplasms

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: phenoxodiol

Drug: carboplatin

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00382811

NV06-0039

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.