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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00459290
First received: April 9, 2007
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: mifepristone
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Mifepristone in the Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free Survival at 6 Months [ 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. ] [ Designated as safety issue: No ]

    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 [ 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. ] [ Designated as safety issue: No ]

    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.


  • Frequency and Severity of Toxicity as Assessed by NCI CTCAE v3.0 [ Time Frame: Every cycle, during treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free Survival [ 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. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Five years ] [ Designated as safety issue: No ]
  • Progression-free Survival by Platinum Sensitivity [ 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. ] [ Designated as safety issue: No ]
    Platinum Senstive defined as treatment free interval >6 months on most recent platinum

  • Progression-free Survival by Performance Status [ 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. ] [ Designated as safety issue: No ]
  • Progression-free Survival by Age (y) [ 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. ] [ Designated as safety issue: No ]

    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.



Enrollment: 24
Study Start Date: May 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone 200 mg PO daily
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.
Drug: mifepristone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459290

  Show 22 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Thomas F. Rocereto, MD Cancer Institute of New Jersey at Cooper - Voorhees
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00459290     History of Changes
Other Study ID Numbers: GOG-0170K
Study First Received: April 9, 2007
Results First Received: January 31, 2014
Last Updated: June 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic

ClinicalTrials.gov processed this record on October 19, 2014