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Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial Cancer. Fallopian Tube, or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00429793
  Purpose

RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer,fallopian tube cancer, or primary peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: temsirolimus
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Official Title: A Phase II Evaluation of CCI-779 (Temsirolimus, NCI-Supplied Agent, NSC # 683864, IND #61010) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month progression-free survival (PFS) [ Designated as safety issue: No ]
  • Objective tumor response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of PFS [ Designated as safety issue: No ]
  • Duration of overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: February 2007
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus.
  • Determine the toxicity of this drug in these patients.

Secondary

  • Determine the duration of PFS and overall survival of these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 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, fallopian tube or primary peritoneal cavity cancer

    • Recurrent or refractory
  • Prior treatment with ≥ 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required

    • Initial treatment may have included any of the following:

      • High-dose therapy
      • Intraperitoneal therapy
      • Consolidation therapy
      • Noncytotoxic agents
      • 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 for patients who received only 1 platinum-based regimen
      • Progressed during platinum-based therapy
      • Refractory disease after a platinum-based regimen
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • Must have ≥ 1 target lesion

      • Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy
  • Not eligible for a higher priority GOG protocol, if one exists

PATIENT CHARACTERISTICS:

  • GOG performance status (PS) 0-2 for patients who have receive one prior regimen OR GOG PS 0-1 for patients who have received 2-3 prior regimens
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • AST ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No neuropathy (sensory and motor) > grade 2
  • Fasting cholesterol < 350 mg/dL
  • Fasting triglycerides < 400 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection requiring antibiotics (with the exception of uncomplicated UTI)
  • No other invasive malignancies within the past 5 years, except for non-melanoma skin cancer, breast cancer, or head and neck cancer

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin

    • Patient must remain free of recurrent or metastatic disease
  • At least 3 years since prior adjuvant chemotherapy for localized breast cancer

    • Patient must remain free of recurrent or metastatic disease
  • At least 3 weeks since other prior therapy directed at the malignant tumor, including immunologic agents
  • No prior temsirolimus
  • No prior cancer treatment that would preclude study therapy
  • No prior radiotherapy to > 25% of marrow-bearing areas
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian cancer
  • No prior non-cytotoxic therapy for management of recurrent or persistent ovarian disease, except for therapy that was part of the primary treatment regimen
  • Two additional cytotoxic regimens (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 ovarian disease allowed
  • Concurrent low molecular weight heparin allowed provided PT/INR ≤ 1.5
  • Concurrent hormone replacement therapy allowed
  • No concurrent amifostine or other protective reagents
  • No concurrent prophylactic filgrastim (G-CSF)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429793

  Show 57 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Kian Behbakht, MD University of Colorado at Denver and Health Sciences Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000528257, GOG-0170I
Study First Received: January 30, 2007
Last Updated: September 18, 2008
ClinicalTrials.gov Identifier: NCT00429793  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Carcinoma
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009