search
Back to results

Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
topotecan hydrochloride
adjuvant therapy
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer Stage IIIB, IIIC, or IV Surgically staged and debulked Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria: No evidence of cancer by history or physical examination CA 125 no greater than 35 units/mL No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray Must have received at least 5 courses of first-line chemotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,200/mm^3 Platelet count at least 90,000/mm^3 Hepatic Bilirubin normal ALT and AST less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 1.5 ULN Renal Creatinine clearance at least 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 3 weeks since prior first-line chemotherapy At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer) No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Radiotherapy No prior abdominopelvic radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics No concurrent surgery Other No other concurrent antitumor therapy

Sites / Locations

  • Beth Israel Deaconess Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
June 25, 2013
Sponsor
Beth Israel Deaconess Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00055614
Brief Title
Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (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. PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy. Determine the safety of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression. Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients. Patients are followed every 2 months for at least 6 months. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer Stage IIIB, IIIC, or IV Surgically staged and debulked Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria: No evidence of cancer by history or physical examination CA 125 no greater than 35 units/mL No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray Must have received at least 5 courses of first-line chemotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,200/mm^3 Platelet count at least 90,000/mm^3 Hepatic Bilirubin normal ALT and AST less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase less than 1.5 ULN Renal Creatinine clearance at least 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 3 weeks since prior first-line chemotherapy At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer) No other concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Radiotherapy No prior abdominopelvic radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics No concurrent surgery Other No other concurrent antitumor therapy
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

12. IPD Sharing Statement

Learn more about this trial

Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

We'll reach out to this number within 24 hrs