Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00026442
First received: November 9, 2001
Last updated: December 17, 2013
Last verified: April 2004
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Trial Of Two Different Doses Of Capecitabine (XELODA) In Patients With Advanced And/Or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026442

Locations
United States, California
Antelope Valley Hospital
Lancaster, California, United States, 93534
Medical Oncology Care Associates
Orange, California, United States, 92868
California Cancer Medical Center
West Covina, California, United States, 91790
United States, Colorado
Oncology Clinic, P.C.
Colorado Springs, Colorado, United States, 80907
United States, Florida
Hematology Oncology Associates of theTreasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States, 34952
North Florida Cancer Center
St. Augustine, Florida, United States, 32086
United States, Maryland
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States, 21236
United States, South Carolina
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, United States, 29403
United States, Tennessee
Family Cancer Center
Collierville, Tennessee, United States, 38017
United States, Utah
Logan Regional Hospital
Logan, Utah, United States, 84341
Sponsors and Collaborators
Pharmatech Oncology
Investigators
Study Chair: Sandy Marcus Pharmatech Oncology
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00026442     History of Changes
Other Study ID Numbers: CDR0000069030, PHARMATECH-XEL-154, PHARMATECH-20010330, ROCHE-PHARMATECH-XEL-154
Study First Received: November 9, 2001
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014