Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Status: | Completed |
---|---|
Conditions: | Ovarian Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 7/20/2018 |
Start Date: | May 2007 |
End Date: | July 2010 |
A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma
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.
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.
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.
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.
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
We found this trial at
22
sites
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1200 Old York Road
Abington, Pennsylvania 19001
Abington, Pennsylvania 19001
(215) 481-2400
Rosenfeld Cancer Center at Abington Memorial Hospital As one of the most trusted cancer centers...
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3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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800 NE 10th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
(855) 750-2273
Oklahoma University Cancer Institute The Peggy and Charles Stephenson Cancer Center is located on the...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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114 Woodland St, Hartford
Hartford, Connecticut 06105
Hartford, Connecticut 06105
(860) 714-4000
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center While better...
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Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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Lake University Ireland Cancer Center Lake Health is a private, not-for-profit leader in community health...
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100 Grand Street
New Britain, Connecticut 06050
New Britain, Connecticut 06050
(860) 224-5299
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus The...
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Methodist Estabrook Cancer Center At Methodist Estabrook Cancer Center, we understand how deeply a diagnosis...
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2809 Denny Ave
Pascagoula, Mississippi 39581
Pascagoula, Mississippi 39581
228-809-5251
Regional Cancer Center at Singing River Hospital The Regional Cancer Center team at Singing River...
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101 Dudley St
Providence, Rhode Island 02905
Providence, Rhode Island 02905
(401) 274-1100
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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3850 S National Ave
Springfield, Missouri 65807
Springfield, Missouri 65807
(417) 269-5257
Hulston Cancer Center at Cox Medical Center South In 1997, the cancer program at CoxHealth...
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100 E Lancaster Ave
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
(484) 476-2000
Lankenau Cancer Center at Lankenau Hospital At Lankenau we pride ourselves on the breadth of...
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