search
Back to results

Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
Sponsored by
Pharmatech Oncology
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically and/or cytologically confirmed breast cancer Advanced and/or metastatic disease At least 1 measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present) No hepatitis Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 50 mL/min Cardiovascular: No clinically significant cardiac disease No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias poorly controlled with medication No myocardial infarction within the past 12 months even if adequately controlled with medication Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No severe pain inadequately controlled by analgesics No prior severe and unexpected reaction to fluoropyrimidine therapy No known hypersensitivity to fluorouracil No impaired physical integrity of the upper gastrointestinal tract No malabsorption syndrome No inability to swallow tablets No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation No serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 but no more than 3 prior chemotherapy regimens At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field No concurrent radiotherapy Surgery: No prior organ allografts Other: At least 4 weeks since prior investigational drug No concurrent enrollment on other investigational study No other concurrent anticancer agents

Sites / Locations

  • Antelope Valley Hospital
  • Medical Oncology Care Associates
  • California Cancer Medical Center
  • Oncology Clinic, P.C.
  • Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
  • North Florida Cancer Center
  • Maryland Hematology/Oncology Associates
  • Charleston Hematology-Oncology, P.A.
  • Family Cancer Center
  • Logan Regional Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 9, 2001
Last Updated
December 17, 2013
Sponsor
Pharmatech Oncology
search

1. Study Identification

Unique Protocol Identification Number
NCT00026442
Brief Title
Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
Official Title
A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Unknown status
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmatech Oncology

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: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.
Detailed Description
OBJECTIVES: Compare the objective response rate in women with advanced or metastatic breast cancer treated with two dose levels of capecitabine. Compare the duration of response, time to progression, time to treatment failure, survival, incidence of adverse events, and time to onset of the adverse experience in patients treated with this drug. Compare the quality of life of patients treated with this drug. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (70-80% vs 90-100%) and presence of hepatic metastases (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive lower-dose oral capecitabine twice daily on days 1-14. Arm II: Patients receive higher-dose oral capecitabine twice daily on days 1-14. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of the third and sixth courses, and at completion of therapy. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically and/or cytologically confirmed breast cancer Advanced and/or metastatic disease At least 1 measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present) No hepatitis Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 50 mL/min Cardiovascular: No clinically significant cardiac disease No congestive heart failure No symptomatic coronary artery disease No cardiac arrhythmias poorly controlled with medication No myocardial infarction within the past 12 months even if adequately controlled with medication Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No severe pain inadequately controlled by analgesics No prior severe and unexpected reaction to fluoropyrimidine therapy No known hypersensitivity to fluorouracil No impaired physical integrity of the upper gastrointestinal tract No malabsorption syndrome No inability to swallow tablets No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation No serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 but no more than 3 prior chemotherapy regimens At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field No concurrent radiotherapy Surgery: No prior organ allografts Other: At least 4 weeks since prior investigational drug No concurrent enrollment on other investigational study No other concurrent anticancer agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy Marcus
Organizational Affiliation
Pharmatech Oncology
Official's Role
Study Chair
Facility Information:
Facility Name
Antelope Valley Hospital
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Cancer Medical Center
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Oncology Clinic, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
North Florida Cancer Center
City
St. Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Maryland Hematology/Oncology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Charleston Hematology-Oncology, P.A.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Family Cancer Center
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38017
Country
United States
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer

We'll reach out to this number within 24 hrs