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A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC# 683864, IND# 61010) in Combination With Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary

Phase 2
18 Years
Open (Enrolling)
Ovarian Clear Cell Cystadenocarcinoma, Stage III Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer

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Trial Information

A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC# 683864, IND# 61010) in Combination With Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary


I. To assess the activity of the study regimen as measured by the proportion of patients who
are alive and progression-free for at least 12 months after study entry in patients with
newly diagnosed Stage III or IV clear cell ovarian cancer in the following populations:
patients in the U.S. and worldwide (outside of Japan) and patients in Japan.

II. To compare progression-free survival in newly diagnosed Stage III or IV clear cell
ovarian cancer patients in patients in the U.S. and worldwide (outside of Japan) versus
patients in Japan.


I. To characterize the duration of overall survival and progression-free survival in each

II. To examine the frequency and severity of adverse events as assessed by CTCAE version 4
in each population.

III. To estimate the rate of objective tumor response in patients with measurable disease.


I. To explore whether immunohistochemical (IHC) expression of components of the mTOR
signaling pathway (PTEN, total and phosphorylated Akt, as well as, ABCC3 (MRP3), AB CF2,
cyclin E, and VEGF) are associated with outcome, nationality or clinical characteristics.

II. To explore whether there is any differences in differential gene expression profiles
between U.S. and worldwide (outside of Japan) versus Japanese patients.

OUTLINE: This is a multicenter study. Patients are stratified according to surgical extent
(optimal vs suboptimal).

Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30
minutes on day 1 and temsirolimus IV on days 1 and 8. Treatment repeats every 3 weeks for 6
courses. Patients then receive consolidation therapy comprising temsirolimus IV on days 1,
8, and 15. For circumstances in which docetaxel should be substituted for paclitaxel,
docetaxel will be given IV over 1 hour. Treatment repeats every 3 weeks for 11 courses in
the absence of disease progression or unacceptable toxicity. Patients may undergo sample
collection for exploratory studies.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Diagnosis of stage III or IV clear cell ovarian cancer

- Primary tumors must be ≥ 50% clear cell histomorphology*

- No primary peritoneal or fallopian tube carcinoma

- Negative for the expression of WT-1 antigen and estrogen receptor (ER) antigen by

- Newly diagnosed disease

- Undergone initial surgery for the combined purpose of diagnosis, staging, and
cytoreduction within the past 2-12 weeks

- GOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Total bilirubin normal

- AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN for patients with liver

- Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN for patients with liver

- Creatinine ≤ 1.5 times ULN

- Cholesterol ≤ 350 mg/dL (fasting)

- Triglycerides ≤ 400 mg/dL (fasting)

- Albumin ≥ 3.0 mg/dL

- PT such that INR is ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient
is on a stable dose of therapeutic warfarin for management of venous thrombosis
including pulmonary thrombo-embolus)

- PTT < 1.2 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 months after
completion of study treatment

- Neurologic function (sensory and motor) ≤ CTCAE grade 1

- No severely impaired lung function, defined as a DLCO ≤ 50% of the normal predicted
value and/or oxygen saturation ≤ 88% at rest on room air

- No baseline requirement for oxygen

- None of the following:

- NYHA class III-IV symptomatic congestive heart failure

- Unstable angina pectoris

- Myocardial infarction within the past 6 months

- Serious uncontrolled cardiac arrhythmia

- Any other clinically significant disease

- No poorly controlled diabetes

- No active infection requiring antibiotics (except for uncomplicated urinary tract

- No active bleeding or pathologic conditions that carry high risk of bleeding, such as
known bleeding disorder, coagulopathy, or tumor involving major vessels

- No other invasive malignancies within the past 5 years except for nonmelanoma skin

- No other serious concurrent illness that, in the opinion of the treating physician,
will place the patient at unreasonable risk from study treatment

- No concurrent live vaccines

- No prior cancer treatment that contraindicates study therapy

- No prior treatment with a mTOR inhibitor (sirolimus, temsirolimus, everolimus),
paclitaxel, or carboplatin

- No prior radiotherapy to any portion of the abdominal cavity or the pelvis

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
allowed provided that it was completed ≥ 5 years before registration and the
patient remains free of recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor, including neoadjuvant
chemotherapy for the clear cell ovarian cancer

- No concurrent maintenance corticosteroids except for short-term (< 5 days) use

- No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine,
phenobarbital), any other CYP3A4 inducer (e.g., rifampin, St. John wort), or strong
CYP3A4 inhibitors

- No other concurrent investigational agents

- No concurrent sunitinib

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Description:

Will be characterized with Kaplan-Meier plots.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

John Farley

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

Related Keywords:

  • Ovarian Clear Cell Cystadenocarcinoma
  • Stage III Ovarian Epithelial Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Cystadenocarcinoma
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms



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