Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Peritoneal Neoplasms, Ovarian Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Daniel P Gold, PhD

Investigator Role:

Study Director

Investigator Affiliation:

MEI Pharma, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

NV06-0039

NCT ID:

NCT00382811

Start Date:

October 2006

Completion Date:

April 2011

Related Keywords:

  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Ovarian Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Peritoneal Cavity Cancer
  • Stage III Ovarian Epithelial Cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Cedars-Sinai Medical CenterLos Angeles, California  90048
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
MetroHealth Medical CenterCleveland, Ohio  44109
Piedmont HospitalAtlanta, Georgia  30309
Miami Valley HospitalDayton, Ohio  45409
Gabrail Cancer CenterCanton, Ohio  44718
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
Arizona Clinical Research Center, Inc.Tucson, Arizona  85712
Jersey Shore Medical CenterNeptune, New Jersey  07754
Chattanooga GYN OncologyChattanooga, Tennessee  37403
Yale University School Of MedicineNew Haven, Connecticut  06520
Gynecologic Oncology AssociatesPembroke Pines, Florida  33028
Associates in Women's HealthWichita, Kansas  67214
Gynecologic Oncology of West MichiganGrand Rapids, Michigan  49546
Schwartz Gynecologic OncologyBrightwaters, New York  11718
Chattanooga's Program in Women's OncologyChattanooga, Tennessee  37403
Northern Virginia Pelvic Surgery AssociatesAnnandale, Virginia  22003
Gynecology Oncology AssociatesGreenbrae, California  
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Sarah Cannon Research InstituteNashville, Tennessee  37203
Kaiser Permanente Los Angeles Medical CenterLos Angeles, California  90027
New York Downtown HospitalNew York, New York  10038
Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3500
Glendale AdventistGlendale, California  91206
Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)Stamford, Connecticut  06902
Greater Baltimore Medical CentreBaltimore, Maryland  21204
Providence Hospital and Medical CentersSouthfield, Michigan  48075
The Center for Cancer & Hematological DiseaseCherry Hill, New Jersey  08003
The University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131-0001
University of Rochester Gynecologic Oncology AssociatesRochester, New York  14620
Brody School of Medical at East Carolina UniversityGreenville, North Carolina  27834
OSU James Cancer Hospital & Solove Research InstituteColumbus, Ohio  43210
Hall and Martin MDS, P.C.Knoxville, Tennessee  37920
Hope Cancer ClinicBrownsville, Texas  78526
University of Texas Southwestern Medical Center Simmons Comprehensive Cancer CenterDallas, Texas  75390
Virginia Mason Medical Center Department of Hematology/OncologySeattle, Washington  98101