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Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
Sponsored by
Theradex
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 stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery

Sites / Locations

  • Oncology Center at Providence Park
  • Hematology Associates, Ltd.
  • Highlands Oncology Group, P.A.
  • Cancer Center of Santa Barbara
  • Good Samaritan Medical Center
  • Decatur Memorial Hospital Cancer Care Institute
  • Creighton University Cancer Center
  • Jersey Shore Cancer Center
  • Women's Health Center at Albany Medical Center
  • Carolinas Medical Center
  • Akron General Medical Center
  • Oncology/Hematology Care, Inc.
  • Cleveland Clinic Cancer Center
  • Women's Cancer Center of Central PA, P.C.
  • Women and Infants Hospital of Rhode Island
  • Brookview Research, Inc.
  • Harrington Cancer Center
  • Rockwood Clinic P.S.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 19, 2011
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00003160
Brief Title
Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum
Official Title
A Phase II Trial of Paclitaxel (Taxol) Administered as a Weekly One Hour Infusion in Patients With Taxol/Platinum-Refractory Stage III and IV Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

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. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women with stage III or stage IV ovarian cancer that is refractory to paclitaxel and platinum-based regimens.
Detailed Description
OBJECTIVES: I. Determine the objective response rate of paclitaxel given as a weekly one hour infusion in patients with paclitaxel/platinum refractory stage III and IV ovarian cancer. II. Evaluate the safety of paclitaxel in this patient population. III. Assess the overall survival in these patients. IV. Assess quality of life in these patients. OUTLINE: This is a multicenter, open label, nonrandomized study. Patients are administered paclitaxel as a one hour IV infusion every 7 days. Each cycle consists of four weeks. Treatment may be delayed for up to 2 weeks and there is no limit to the number of interruptions a patient may experience. Patients receive paclitaxel weekly until disease progression or unacceptable toxicity. Treatment is assessed every 3 cycles for one year and then every 6 months thereafter during study. Quality of life is assessed every cycle for the first 6 cycles, then every 3 cycles thereafter. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: There will be 100 patients accrued into 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
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer that is refractory to an initial chemotherapy regimen that included a platinum agent plus paclitaxel - Epithelial ovarian cancer - Primary carcinoma of the peritoneum - Fallopian tube cancer Initial response to platinum and paclitaxel must have been one of the following: Progression or stable disease Response that lasted less than 3 months Response that lasted at least 3 months, but when retreated with both agents (in combination or as single agents) disease was refractory Measurable or evaluable disease Evaluable disease is defined by: CA-125 at least 100 units/mL AND CA-125 level must have at least doubled from baseline determination PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association Class III or IV heart disease No myocardial infarction within last 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Neurology: No current peripheral neuropathy of any etiology that is greater than grade 1 Other: No active serious infection or other serious underlying medical condition No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporin, or vitamin K Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since immunotherapy No concurrent immunotherapy Chemotherapy: Prior paclitaxel treatment must have been administered on a 3 week or greater schedule No other prior chemotherapy besides platinum and paclitaxel At least 3 weeks since acceptable chemotherapy Endocrine therapy: At least 3 weeks since hormonal therapy No concurrent hormonal therapy Radiotherapy: At least 3 weeks since radiotherapy No prior radiation to greater than 30% of bone marrow Surgery: At least 3 weeks since major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurie Markman, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Oncology Center at Providence Park
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Hematology Associates, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Highlands Oncology Group, P.A.
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Cancer Center of Santa Barbara
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Good Samaritan Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Creighton University Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
Jersey Shore Cancer Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Women's Health Center at Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12209
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Oncology/Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Women's Cancer Center of Central PA, P.C.
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17105-8700
Country
United States
Facility Name
Women and Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Rockwood Clinic P.S.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

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Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum

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