Brief Title
Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free Survival at 6 Months
Secondary Outcome
Progression-free Survival
Condition
Fallopian Tube Cancer
Intervention
mifepristone
Study Arms / Comparison Groups
Mifepristone 200 mg PO daily
Description: 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.
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
24
Start Date
May 2007
Completion Date
July 2010
Primary Completion Date
July 2010
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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Thomas F. Rocereto, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00459290
Organization ID
GOG-0170K
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Study Sponsor
Thomas F. Rocereto, MD, Study Chair, Cancer Institute of New Jersey at Cooper - Voorhees
Verification Date
June 2014