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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459290
• Other study ID #: GOG-0170K
• Status: Completed
• Phase: Phase 2
• Start date: May 2007
• Est. completion date: July 2010

Study information

• Verified date: June 2014
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• mifepristone

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut
United States	Hinsdale Hematology Oncology Associates	Hinsdale	Illinois
United States	Freeman Cancer Institute at Freeman Health System	Joplin	Missouri
United States	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Maine Medical Center - Bramhall Campus	Portland	Maine
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival at 6 Months	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.; CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.	Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
Primary	Proportion of Patients With Objective Tumor Response	Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.; CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.	Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
Primary	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0		Every cycle, during treatment (average of 3 months).
Secondary	Progression-free Survival	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.; CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.	Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
Secondary	Overall Survival		Five years
Secondary	Progression-free Survival by Platinum Sensitivity	Platinum Senstive defined as treatment free interval >6 months on most recent platinum	Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
Secondary	Progression-free Survival by Performance Status		Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.
Secondary	Progression-free Survival by Age (y)	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.; CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.	Every other cycle, for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels.