Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma*

Recurrent or refractory disease NOTE: *Histological confirmation of original primary tumor required

Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, and MRI OR ≥ 10 mm by spiral CT scan

Must have ≥ 1 target lesion

Tumors within a previously irradiated field are designated as nontarget lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy

Prior treatment with 1 platinum-based chemotherapeutic regimen (comprising carboplatin, cisplatin, or another organoplatinum compound) for management of primary disease required

Initial treatment may have included any of the following:

High-dose therapy
Consolidation therapy
Extended therapy administered after surgical or nonsurgical assessment

Patients must meet ≥ 1 of the following criteria:

Treatment-free interval after platinum therapy of < 12 months
Progressed during platinum-based therapy
Persistent disease after a platinum-based regimen
Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00459290

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 22 Locations for this study

See Locations Near You

Kaiser Permanente Medical Center - Los Angeles
Los Angeles California, 90027, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain Connecticut, 06050, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Woman's Hospital
Baton Rouge Louisiana, 70815, United States
Maine Medical Center - Bramhall Campus
Portland Maine, 04102, United States
Regional Cancer Center at Singing River Hospital
Pascagoula Mississippi, 39581, United States
Freeman Cancer Institute at Freeman Health System
Joplin Missouri, 64804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
Lake/University Ireland Cancer Center
Mentor Ohio, 44060, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Women and Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00459290

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

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