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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00459290
First received: April 9, 2007
Last updated: April 23, 2011
Last verified: October 2007
  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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proportion of patients with progression-free survival for at least 6 months [ Designated as safety issue: No ]
  • Proportion of patients with objective tumor response [ Designated as safety issue: No ]
  • Frequency and severity of toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Designated as safety issue: No ]
  • Duration of overall survival [ Designated as safety issue: No ]
  • Prognostic potential of platinum sensitivity, initial performance status, and age [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: May 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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
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
Investigator: Leslie R. DeMars, MD Norris Cotton Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00459290     History of Changes
Other Study ID Numbers: CDR0000539243, GOG-0170K
Study First Received: April 9, 2007
Last Updated: April 23, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube 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
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists

ClinicalTrials.gov processed this record on April 15, 2014