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

Brief Title

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

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

Brief Summary

      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.

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

6 Month Progression-free Survival (PFS)

Secondary Outcome

 Duration of Progression-free Survival

Condition

Fallopian Tube Cancer

Intervention

temsirolimus

Study Arms / Comparison Groups

 Treatment (temsirolimus)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

February 2007

Completion Date

January 2012

Primary Completion Date

January 2012

Eligibility 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)

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kian Behbakht, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00429793

Organization ID

NCI-2012-02707

Secondary IDs

NCI-2012-02707

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)

Collaborators

 Gynecologic Oncology Group

Study Sponsor

Kian Behbakht, Principal Investigator, Gynecologic Oncology Group

Verification Date

July 2019