Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors

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