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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with progression-free survival for at least 6 months

Safety Issue:

No

Principal Investigator

Thomas F. Rocereto, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey at Cooper - Voorhees

Authority:

United States: Federal Government

Study ID:

CDR0000539243

NCT ID:

NCT00459290

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Kaiser Permanente Medical Center - Los Angeles Los Angeles, California  90027
University of Texas Medical Branch Galveston, Texas  77555-1329
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Maine Medical Center - Bramhall Campus Portland, Maine  04102
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Woman's Hospital Baton Rouge, Louisiana  70815
Freeman Cancer Institute at Freeman Health System Joplin, Missouri  64803-2644
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792