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

NCT00194727 | Completed Phase 2

• 2 other identifiers: 20912-A02-1544-A 06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Best response as determined at the time that the subject completes protocol treatment

  <= 4 years

Secondary Outcomes (4)

• Time to progression as determined at the time that each subject's disease worsens following treatment

  <= 4 years

• Median survival at two and three years following the start of protocol treatment.

  <= 3 years

• Correlation between intra-tumoral enzyme levels and prognosis

  <= 4 years

• Measure the toxicity of the regimen

  During study treatment

Study Arms (1)

1

EXPERIMENTAL

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.

Drug: Vinorelbine; Drug: Capecitabine

Interventions

Vinorelbine DRUG

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.

1

Capecitabine DRUG

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.

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Hoffmann-La Roche: collaborator
• Pfizer: collaborator

Study Sites (1)

University of Washington; Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Georgiana K. Ellis, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2002
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

US (1)