Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer

NCT00194727

Last updated date
Study Location
University of Washington; Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject must be older than 18 and younger than 85.

- Subject must have metastatic (stage IV) breast cancer.

- Subject must have pathologic confirmation of breast cancer (at least of primary disease). Biopsy confirmation of stage IV disease is desirable but not required. Tissue blocks must be available for review.

- Subject must have measurable or non-measurable disease as defined below:

Measurable disease includes lesions that can be accurately measured in at least one dimension as greater than 2.0 cm with conventional techniques or as greater than 1.0 cm with spiral CT scan.

Non-measurable disease includes all other lesions (e.g. lesions less than 2.0 cm by conventional techniques or less than 1.0 cm by spiral CT, bone lesions, pleural effusion, etc.).

- Subject must be willing and able to provide informed consent.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subject must not have significant co-morbid conditions such as clinically significant
cardiac disease not well controlled with medication (e.g. congestive heart failure,
symptomatic coronary artery disease and cardiac arrhythmias), or myocardial infarction
within the last 12 months or serious concurrent infection.


- Subject must not have rapidly progressing visceral involvement (e.g. liver,
lymphangitic lung).


- Subject must not have evidence of CNS metastases.


- Subject must not have abnormal hematologic values (neutrophils less than 1.5 x 103/uL,
platelet count less than 100 x 103/uL).


- Subject must not have impaired renal function (serum creatinine greater than 1.5 x
upper normal limit) or estimated creatinine clearance below 30 mL/min by the Cockcroft
and Gault equation.


- Subject must not have serum bilirubin greater than 1.5 x upper normal limit.


- Subject must not have ALT or AST greater than 2.5 x upper normal limit (or greater
than 5 x upper normal limit in the case of liver metastases).


- Subject must not have alkaline phosphatase greater than 2.5 x upper normal limit (or
greater than 5 x upper normal limit in the case of liver metastases or greater than 10
x upper normal limit in the case of bone disease).


- Subject must not have a lack of physical integrity of the upper gastrointestinal
tract, inability to swallow or malabsorption syndrome


- Subject must not have a history of fluoropyrimidine therapy (unless given in an
adjuvant setting and completed at least 12 months earlier).


- Subject must not have a life expectancy less than 3 months.


- Subject must not have a Karnofsky Performance Status less than 70%.


- Subject must not have a history of another carcinoma within the last five years except
non-melanoma skin and treated in-situ cervical cancer.


- Subject must not have a history of unanticipated severe reaction to fluoropyrimidine
therapy, or known sensitivity to 5-fluorouracil.


- Subject must not have organ allografts.


- Subject must not be pregnant or lactating woman. (Postmenopausal woman must have been
amenorrheic for at least 12 months to be considered of non-childbearing potential).


- Subject must not be less than four weeks from completion of previous chemotherapy
regimen or with related toxicities unresolved prior to the start of study treatment.


- Subject must not be less than four weeks from major surgery or without complete
recovery.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer
Official Title  ICMJE Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer: A Phase II Trial With Molecular Correlates
Brief Summary The primary purpose of the study is to examine the safety and effectiveness of combination therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV breast cancer subjects. The study is designed to assess the safety and effectiveness of this combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will be assessed by analyzing response rates, time to treatment failure, time to progression and overall survival. Our hypothesis is that the regimen will be more effective than standard historic regimens for this type and stage of cancer.
Detailed Description

Single-agent chemotherapy is rarely curative in advanced breast cancer. Combination regimens are the next logical step in the attempt to improve tumor response rates and prolong survival. Oral capecitabine is a convenient way to deliver drug a 5-fluorouracil analogue. In addition, vinorelbine is a newer vinca alkaloid chemotherapeutic agent with improved efficacy and probably improved toxicity over its predecessors in the treatment of breast cancer. We propose combining these two agents. As these two drugs have non-overlapping toxicities and differing mechanisms of action, we anticipate being able to deliver both drugs in near full dose.

Secondary purposes include assessing whether there is a correlation between intra-tumoral enzyme levels and prognosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasm
Intervention  ICMJE
  • Drug: Vinorelbine
    20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
  • Drug: Capecitabine
    825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
Study Arms  ICMJE Experimental: 1
Vinorelbine (20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle) and capecitabine (825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle). Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
Interventions:
  • Drug: Vinorelbine
  • Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be older than 18 and younger than 85.
  • Subject must have metastatic (stage IV) breast cancer.
  • Subject must have pathologic confirmation of breast cancer (at least of primary disease). Biopsy confirmation of stage IV disease is desirable but not required. Tissue blocks must be available for review.
  • Subject must have measurable or non-measurable disease as defined below:

Measurable disease includes lesions that can be accurately measured in at least one dimension as greater than 2.0 cm with conventional techniques or as greater than 1.0 cm with spiral CT scan.

Non-measurable disease includes all other lesions (e.g. lesions less than 2.0 cm by conventional techniques or less than 1.0 cm by spiral CT, bone lesions, pleural effusion, etc.).

- Subject must be willing and able to provide informed consent.

Exclusion Criteria:

  • Subject must not have significant co-morbid conditions such as clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias), or myocardial infarction within the last 12 months or serious concurrent infection.
  • Subject must not have rapidly progressing visceral involvement (e.g. liver, lymphangitic lung).
  • Subject must not have evidence of CNS metastases.
  • Subject must not have abnormal hematologic values (neutrophils less than 1.5 x 103/uL, platelet count less than 100 x 103/uL).
  • Subject must not have impaired renal function (serum creatinine greater than 1.5 x upper normal limit) or estimated creatinine clearance below 30 mL/min by the Cockcroft and Gault equation.
  • Subject must not have serum bilirubin greater than 1.5 x upper normal limit.
  • Subject must not have ALT or AST greater than 2.5 x upper normal limit (or greater than 5 x upper normal limit in the case of liver metastases).
  • Subject must not have alkaline phosphatase greater than 2.5 x upper normal limit (or greater than 5 x upper normal limit in the case of liver metastases or greater than 10 x upper normal limit in the case of bone disease).
  • Subject must not have a lack of physical integrity of the upper gastrointestinal tract, inability to swallow or malabsorption syndrome
  • Subject must not have a history of fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 12 months earlier).
  • Subject must not have a life expectancy less than 3 months.
  • Subject must not have a Karnofsky Performance Status less than 70%.
  • Subject must not have a history of another carcinoma within the last five years except non-melanoma skin and treated in-situ cervical cancer.
  • Subject must not have a history of unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
  • Subject must not have organ allografts.
  • Subject must not be pregnant or lactating woman. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Subject must not be less than four weeks from completion of previous chemotherapy regimen or with related toxicities unresolved prior to the start of study treatment.
  • Subject must not be less than four weeks from major surgery or without complete recovery.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00194727
Other Study ID Numbers  ICMJE 20912-A
02-1544-A 06 ( Other Identifier: UW Human Subjects Division )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • Hoffmann-La Roche
  • Pfizer
Investigators  ICMJE
Principal Investigator:Georgiana K. Ellis, M.D.University of Washington
PRS Account University of Washington
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP