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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer  CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
For Condition: Endometrial Cancer
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as CCI-779, use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic or locally advancedrecurrentendometrial cancer.
Details: OBJECTIVES: Primary - Determine the efficacy of CCI-779, in terms of response rate and duration of stable disease, in patients with metastatic or locally advanced recurrent endometrial cancer. - Determine the adverse events, time to progression, and response duration in patients treated with this drug. Secondary - Correlate objective tumor response with PTEN expression and other molecular measures in the tumor tissue of these patients obtained at diagnosis (primary tumor). OUTLINE: This is a nonrandomized, multicenter study. Patients receive CCI-779 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. Patients are followed at 4 weeks after study completion. Patients who have not yet progressed are followed every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic or locally advanced recurrent endometrial carcinoma, including 1 of the following types: - Adenocarcinoma - Papillary serous - Papillary - Villoglandular - Mucinous - Clear cell - Endometrioid - Adenosquamous - At least 1 unidimensionally measurable site of disease* meeting at least 1 of the following criteria: - At least 20 mm by x-ray or physical exam - At least 10 mm by spiral CT scan - At least 20 mm by non-spiral CT scan NOTE: *Bone metastases are considered nonmeasurable - Not curable by standard therapy - Available tissue from the primary tumor - No uterine sarcomas (leiomyosarcoma), mixed mullerian tumors, or adenosarcomas - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN OR - Creatinine clearance at least 50 mL/min Cardiovascular - No myocardial infarction within the past 6 months - No serious cardiovascular illness - No congestive heart failure - No unstable angina - No active cardiomyopathy - No unstable ventricular arrhythmia - No uncontrolled hypertension Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Fasting cholesterol no greater than 9.0 mmol/L - Fasting triglycerides no greater than 4.56 mmol/L - No other prior or concurrent malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years - No history of allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 - No history of significant neurologic or psychiatric disorder that would preclude the ability to give consent or limit compliance with study requirements - No serious illness or medical condition that would preclude management of the patient according to study guidelines - No active uncontrolled infection - No active peptic ulcer disease - No medical condition that would be aggravated by study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic hematopoietic colony-stimulating factor therapy Chemotherapy - No prior chemotherapy Endocrine therapy - At least 1 week since prior hormonal therapy - No more than 1 prior hormonal treatment (progestational or aromatase inhibitor) as either adjuvant therapy or for treatment of metastatic disease Radiotherapy - At least 28 days since prior radiotherapy and recovered - No concurrent radiotherapy to the sole site of measurable disease before assessment of response Surgery - At least 21 days since prior major surgery and recovered Other - No other concurrent investigational therapy - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmitOza, Study Chair, Princess Margaret Hospital
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Amit Oza 416-946-2818
Additional Information:
Study ID Numbers: CDR0000335543; CAN-NCIC-IND160
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072176
Other Endometrial Cancer Studies:
1. Hormone Therapy in Preventing Endometrial Carcinogenesis (Cancer) in Women With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer
2. Gene Therapy in Treating Patients With Cancer
3. Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
4. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
5. Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
Related Studies:
Other Endometrial Cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
CCI-779 in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
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