Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00429793
First received: January 30, 2007
Last updated: April 30, 2014
Last verified: December 2012
  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. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Condition Intervention Phase
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Drug: temsirolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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, Fallopian Tube or Primary Peritoneal Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 6 Month Progression-free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of participants who survived progression-free for more than 6 months.

  • Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.

  • Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of PFS [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.

  • Duration of Overall Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Characterized with Kaplan-Meier plots and estimates of the median time until death or progression.


Other Outcome Measures:
  • Reason Off Study Therapy [ Time Frame: from study entry until end of study treatment ] [ Designated as safety issue: No ]
  • Patient Vital Status [ Time Frame: Study entry up to 2 years ] [ Designated as safety issue: No ]
    Patients alive or dead after 24 months from time of study entry


Enrollment: 60
Study Start Date: February 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (temsirolimus)
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.
Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel

Detailed Description:

OBJECTIVES: Primary I. 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.

II. Determine the toxicity of this drug in these patients.

Secondary I. 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

Inclusion Criteria:

  • 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
  • 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
  • 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
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: NCT00429793

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Investigators
Principal Investigator: Kian Behbakht Gynecologic Oncology Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00429793     History of Changes
Other Study ID Numbers: NCI-2012-02707, NCI-2012-02707, CDR0000528257, GOG-0170I, GOG-0170I, U10CA027469
Study First Received: January 30, 2007
Results First Received: July 9, 2013
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 30, 2014