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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

carboplatin

docetaxel

gemcitabine hydrochloride

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beth Israel Deaconess Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004082

First Posted

December 10, 1999

Last Updated

June 25, 2013

Sponsor

Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00004082

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

July 1999 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen A. Cannistra, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial