Completed

Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

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What is being tested

bevacizumab

+ capecitabine
+ docetaxel
Biological
Drug
Who is being recruted

Breast Cancer

Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2004

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: December 7, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2004Actual date on which the first participant was enrolled.

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer. OBJECTIVES: Primary * Determine the response rate in patients with metastatic breast cancer treated with docetaxel, capecitabine, and bevacizumab as first-line chemotherapy. Secondary * Determine time to disease progression in patients treated with this regimen. * Determine survival of patients treated with this regimen. * Determine the toxicity profile of this regimen in these patients. * Determine the duration of response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Official TitlePhase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer 
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: December 7, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
46 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive breast cancer * Clinical evidence of metastatic disease * No bone metastases as the only evidence of metastasis * Measurable disease * At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan * Lesions on chest x-ray allowed provided they are clearly defined and surrounded by aerated lung * Clincal lesions only considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes) * Target lesion must not have been exposed to prior radiotherapy unless disease has progressed since completion of radiotherapy * The following are not considered measurable disease: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Inflammatory breast disease * Lymphangitis cutis or pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing therapy alone or with antiestrogen hormonal therapy for metastatic disease OR trastuzumab is contraindicated * Prior breast cancer allowed * No prior or active brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * No bleeding diathesis or uncontrolled coagulopathy Hepatic * Bilirubin normal * Meets 1 of the following criteria: * AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN * AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal Renal * Creatinine clearance ≥ 30 mL/min * No proteinuria OR * Protein \< 1 g by 24-hour urine collection * No nephrotic syndrome Cardiovascular * No uncontrolled hypertension (i.e., blood pressure \> 160/90 mm Hg on ≥ 2 different observations ≥ 5 minutes apart) * Blood pressure \< 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for patients who recently began or adjusted anti-hypertensive medication * No atrial or venous thrombosis within the past month * No clinically significant heart disease, including any of the following: * Congestive heart failure * Symptomatic coronary artery disease * Uncontrolled cardiac arrhythmias * Unstable angina * No myocardial infarction within the past 12 months * No history of cerebrovascular accident Pulmonary * No hemoptysis within the past 6 months Gastrointestinal * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * Able to receive oral medication Other * No other stage III or IV invasive malignancy requiring treatment within the past 5 years * No pre-existing peripheral neuropathy \> grade 1 * No history of allergy or hypersensitivity to study drugs, agents that are chemically similar to study drugs, or drugs that contain polysorbate 80 * No prior severe reaction to fluoropyrimidines * No known hypersensitivity to fluorouracil * No known dihydropyrimidine dehydrogenase deficiency * No active infection * No significant medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No other concurrent biologic therapy Chemotherapy * Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease * No prior chemotherapy for metastatic disease * More than 4 weeks since prior cytotoxic chemotherapy * More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel) * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy to a target lesion * Prior single-dose palliative radiotherapy allowed within the past 4 weeks * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery Other * More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents * Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access device allowed * More than 4 weeks since prior investigational agents * No concurrent aspirin, anticoagulants, or thrombolytic agents * No concurrent participation in another clinical trial involving investigational agents or procedures


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

CompletedNo study centers