Brief Title
Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
Official Title
A Phase I Study of Docetaxel (Taxotere), Carboplatin, and Gemcitabine (DoCaGem) as First-Line Therapy for Patients With High-Risk Epithelial Tumors of Mullerian Origin
Brief Summary
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.
Detailed Description
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.
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Endometrial Cancer
Intervention
carboplatin
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
Start Date
July 1999
Completion Date
December 2010
Primary Completion Date
September 2003
Eligibility 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
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More 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 other debilitating
medical or psychiatric conditions that would preclude study No other malignancy within the
past 3 years except limited stage basal or squamous cell skin cancer or carcinoma in situ
of the cervix No evidence of infection Adequate bowel function, oral intake, and wound
healing ability
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cytokine therapy for epithelial tumors
of mullerian origin Chemotherapy: No more than 1 prior chemotherapy regimen for epithelial
tumors of mullerian origin At least 3 years since other prior chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: See Disease
Characteristics At least 7 days since prior surgery
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stephen A. Cannistra, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00004082
Organization ID
BIH-99-1285
Secondary IDs
CDR0000067293
Study Sponsor
Beth Israel Deaconess Medical Center
Study Sponsor
Stephen A. Cannistra, MD, Study Chair, Beth Israel Deaconess Medical Center
Verification Date
November 2010