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


Phase 1
18 Years
N/A
Not Enrolling
Both
Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen A. Cannistra, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

BIH-99-1285

NCT ID:

NCT00004082

Start Date:

July 1999

Completion Date:

December 2010

Related Keywords:

  • Endometrial Cancer
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • endometrial adenocarcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Adenoma

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215