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

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer

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.

Related papers

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Interventions

DRUGmifepristone

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 120 Years

Healthy volunteers

No

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free Survival at 6 Months	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.	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.
Proportion of Patients With Objective Tumor 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.	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.
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

Measure	Time frame	Description
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.	—
Progression-free Survival	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.	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.
Progression-free Survival by Age (y)	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.	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.
Overall Survival	Five years	—
Progression-free Survival by Platinum Sensitivity	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.	Platinum Senstive defined as treatment free interval \>6 months on most recent platinum

Countries

United States

Participant flow

Recruitment details

The study was activated on 5/7/2007 and closed to accrual on 10/29/2007.

Participants by arm

Arm	Count
Mifepristone Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy	22
Total	22

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	3
Overall Study	Ineligible	2

Baseline characteristics

Characteristic	Mifepristone
Age, Customized 40-49 years	1 participants
Age, Customized 50-59 years	6 participants
Age, Customized 60-69 years	8 participants
Age, Customized 70-79 years	6 participants
Age, Customized 80-89 years	1 participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	20 / 22
serious Total, serious adverse events	8 / 22

Outcome results

Primary

Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Time frame: Every cycle, during treatment (average of 3 months).

Population: Eligible and treated patients

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Mifepristone	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Anemia	1 Participants
Mifepristone	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Coagulation	2 Participants
Mifepristone	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Dermatologic	1 Participants
Mifepristone	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Gastrointestinal	1 Participants
Mifepristone	Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	Hemorrhage	1 Participants

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.

Time frame: 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.