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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

Phase 2
18 Years
Not Enrolling
Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Thank you

Trial Information

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

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.

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)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Kian Behbakht

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Primary Peritoneal Cavity Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



Gynecologic Oncology GroupPhiladelphia, Pennsylvania  19103