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Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
topotecan hydrochloride
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer Recurrent or persistent platinum-refractory disease, as defined by 1 of the following: Progressive disease while on a platinum compound Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy Recurrent disease within 6 months after completion of therapy Measurable or evaluable disease Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests) Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-3 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Creatinine clearance > 50 mL/min Other No clinically significant infection No other severe medical condition that would preclude study treatment No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug At least 3 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy and recovered Surgery Recovered from recent prior surgery

Sites / Locations

  • University of Washington School of Medicine

Outcomes

Primary Outcome Measures

Toxicity
Response rate
Quality of life

Secondary Outcome Measures

Progression-free survival
Overall survival

Full Information

First Posted
September 20, 2005
Last Updated
September 20, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217555
Brief Title
Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title
Phase II Trial for the Treatment of Recurrent or Persistent Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With Gemcitabine and Topotecan
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with topotecan works in treating patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cavity cancer.
Detailed Description
OBJECTIVES: Primary Determine the nature and degree of toxicity of gemcitabine and topotecan in patients with recurrent or persistent platinum-refractory ovarian, fallopian tube, or primary peritoneal cavity cancer. Determine the response rate in patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Secondary Determine the duration of progression-free survival and overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and topotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond documentation of CR. Quality of life is assessed at baseline, on day 1 of courses 2, 4, and 6, and then at 1 year. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 36-45 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Primary Outcome Measure Information:
Title
Toxicity
Title
Response rate
Title
Quality of life
Secondary Outcome Measure Information:
Title
Progression-free survival
Title
Overall survival

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of ovarian, fallopian tube, or primary peritoneal cavity cancer Recurrent or persistent platinum-refractory disease, as defined by 1 of the following: Progressive disease while on a platinum compound Persistent clinically measurable disease with best response as stable disease at the completion of ≥ 6 courses of therapy Recurrent disease within 6 months after completion of therapy Measurable or evaluable disease Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests) Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI, OR ≥ 10 mm by spiral CT scan PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-3 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Creatinine clearance > 50 mL/min Other No clinically significant infection No other severe medical condition that would preclude study treatment No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Prior gemcitabine or topotecan allowed provided disease is not refractory to either drug At least 3 weeks since prior chemotherapy and recovered Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy and recovered Surgery Recovered from recent prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A. Goff, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18538834
Citation
Goff BA, Holmberg LA, Veljovich D, Kurland BF; Puget Sound Oncology Consortium. Treatment of recurrent or persistent platinum-refractory ovarian, fallopian tube or primary peritoneal cancer with gemcitabine and topotecan: a phase II trial of the Puget Sound Oncology Consortium. Gynecol Oncol. 2008 Aug;110(2):146-51. doi: 10.1016/j.ygyno.2008.04.037. Epub 2008 Jun 6.
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Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

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