Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

NCT ID: NCT00459290

Last Updated: 2018-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-07-31

Brief Summary

RATIONALE: Progesterone can cause the growth of ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer. Hormone therapy using mifepristone may fight ovarian epithelial cancer and primary peritoneal cancer by lowering the amount of progesterone the body makes.

PURPOSE: This phase II trial is studying the side effects and how well mifepristone works in treating patients with recurrent or persistent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the antitumor activity of mifepristone in patients with recurrent or persistent ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.
• Determine the toxicity of this drug in these patients.

Secondary

• Determine the duration of progression-free survival and overall survival of patients treated with this drug.
• Determine the potential impact of platinum sensitivity, initial performance status, and age on prognosis in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral mifepristone once daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mifepristone 200 mg PO daily

Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks is considered one cycle) until disease progression or adverse effects prohibit further therapy.

Group Type: EXPERIMENTAL

mifepristone

Intervention Type: DRUG

Interventions

mifepristone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• GOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• No active infection requiring antibiotics
• No other invasive malignancies within the past 5 years, except non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior surgery, radiotherapy, or chemotherapy
• No prior cancer treatment that would preclude protocol therapy
• No prior radiotherapy to any portion of the abdominal cavity or pelvis unless for treatment of ovarian cancer

• Prior radiotherapy for localized cancer of the breast, head and neck, or skin is permitted, provided it was completed > 3 years prior to study entry and no recurrent or metastatic disease exists
• No prior chemotherapy to any portion of the abdominal cavity or pelvis unless for treatment of ovarian cancer

• Prior chemotherapy for localized cancer of the breast is permitted, provided it was completed > 3 years prior to study entry and no recurrent or metastatic disease exists
• At least 1 week since prior hormonal therapy directed at the malignant tumor
• At least 2 weeks since other prior hormonal therapy (e.g., testosterone, estrogen, progestin, or gonadotropin-releasing hormone antagonists)
• At least 3 weeks since other prior therapy directed at the malignant tumor, including biological or immunologic agents
• One prior cytotoxic regimen (defined as any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa) for management of recurrent or persistent disease allowed
• No prior non-cytotoxic therapy for management of recurrent or persistent ovarian epithelial or primary peritoneal carcinoma
• No prior mifepristone

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas F. Rocereto, MD

Role: STUDY_CHAIR

Cancer Institute of New Jersey at Cooper - Voorhees

Locations

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

New Britain, Connecticut, United States

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Woman's Hospital

Baton Rouge, Louisiana, United States

Maine Medical Center - Bramhall Campus

Portland, Maine, United States

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Freeman Cancer Institute at Freeman Health System

Joplin, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Lake/University Ireland Cancer Center

Mentor, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, United States

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

University of Texas Medical Branch

Galveston, Texas, United States

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Countries

United States

References

Rocereto TF, Brady WE, Shahin MS, Hoffman JS, Small L, Rotmensch J, Mannel RS. A phase II evaluation of mifepristone in the treatment of recurrent or persistent epithelial ovarian, fallopian or primary peritoneal cancer: a gynecologic oncology group study. Gynecol Oncol. 2010 Mar;116(3):332-4. doi: 10.1016/j.ygyno.2009.10.071. Epub 2009 Nov 17.

Reference Type: RESULT

PMID: 19922989 (View on PubMed)

Other Identifiers

GOG-0170K

Identifier Type: -

Identifier Source: org_study_id