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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors  Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
For Condition: stage 3 endometrial cancer,stage 4 endometrial cancer,peritoneal cavity cancer,endometrial adenocarcinoma,Fallopian Tube Cancer,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): Beth Israel Deaconess Medical Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining docetaxel , carboplatin, and gemcitabine in treating patients who have previously untreated, newly diagnosed epithelial cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel, carboplatin, and gemcitabine in patients with previously untreated, newly diagnosed, high risk epithelial cancer of mullerian origin. PROTOCOL OUTLINE: This is a dose escalation study of docetaxel and gemcitabine. Patients receive docetaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Carboplatin IV is administered over 30 minutes on day 1. Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of docetaxel and gemcitabine until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 1.5-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, newly diagnosed, high risk epithelial tumors of mullerian origin, including: Ovarian epithelial cancer; Peritoneal papillary serous cancer; Primary fallopian tube cancer; Endometrial cancer - High risk is defined as: Any amount of gross residual disease remaining at the time of initial debulking surgery AND/OR Any radiographic or physical exam evidence of disease after surgery AND/OR Disease outside of the abdomen (e.g., malignant pleural effusion) AND/OR Parenchymal liver, spleen, or lung metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prior cytokine therapy for epithelial tumors of mullerian origin - Chemotherapy: No prior chemotherapy for epithelial tumors of mullerian origin; At least 3 years since other prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior pelvic radiotherapy - Surgery: At least 7 days since prior surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Greater than 2 months - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN; SGOT and SGPT no greater than 1.5 times ULN - Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 35 mL/min - Cardiovascular: Acceptable cardiac exam; No active cardiac ischemia - Pulmonary: Acceptable pulmonary exam; No active pulmonary infection or compromise - Other: Not pregnant or nursing; No peripheral neuropathy grade 2 or greater; No debilitating psychiatric or medical conditions interfering with chemotherapy administration; No other malignancy within the past 3 years, except: Limited stage basal or squamous cell skin cancer Carcinoma in situ of the cervix; Adequate bowel function, oral intake, and wound healing ability; No evidence of infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenCannistra, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: CDR0000067293; BIH-99-1285,NCI-V99-1566
Study Start Date: July 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004082
Other Endometrial Adenocarcinoma Studies:
1. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
2. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
3. Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
4. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
5. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Related Studies:
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Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
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