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Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
exatecan mesylate
Sponsored by
Daiichi Sankyo, Inc.
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, recurrent 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 recurrent, metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and topotecan Must have received at least 1 prior chemotherapy regimen Resistance to platinum, taxane, and topotecan is defined as the following: Progressive disease while on chemotherapy OR Relapse within six months of completing chemotherapy OR Failure to achieve complete response after six courses of chemotherapy No recurrent or metastatic disease amenable to attempted curative therapy with surgery and/or radiotherapy Measurable disease No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No psychiatric disorder or mental disability No other malignancy within past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No other life threatening illness No history of camptothecin derivative allergy PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery No concurrent surgery Other: At least 4 weeks since other prior investigational drugs No other concurrent investigational drugs and for 4 weeks after study treatment

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00004060
Brief Title
Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer
Official Title
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced Ovarian, Tubal, or Peritoneal Cancer Refractory to Platinum, Taxane and Topotecan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
September 2000 (Actual)
Study Completion Date
September 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

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 II trial to study the effectiveness of DX-8951f in treating patients who have recurrent, metastatic, or unresectable ovarian, fallopian tube, or peritoneal cancer.
Detailed Description
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in patients with recurrent, metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and topotecan. II. Evaluate the quantitative and qualitative toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics of this regimen in these patients. OUTLINE: Patients are stratified by prior chemotherapy (minimally pretreated vs heavily pretreated). Patients receive intravenous DX-8951f over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: Approximately 37 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, recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exatecan mesylate

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, metastatic, or unresectable ovarian, tubal, or peritoneal carcinoma that is refractory to platinum, taxane, and topotecan Must have received at least 1 prior chemotherapy regimen Resistance to platinum, taxane, and topotecan is defined as the following: Progressive disease while on chemotherapy OR Relapse within six months of completing chemotherapy OR Failure to achieve complete response after six courses of chemotherapy No recurrent or metastatic disease amenable to attempted curative therapy with surgery and/or radiotherapy Measurable disease No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent serious infection No psychiatric disorder or mental disability No other malignancy within past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No other life threatening illness No history of camptothecin derivative allergy PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery No concurrent surgery Other: At least 4 weeks since other prior investigational drugs No other concurrent investigational drugs and for 4 weeks after study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. DeJager, MD, FACP
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer

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