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A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer

A Phase II Trial of Biweekly Gemcitabine, Paclitaxel, and Avastin as Frontline Therapy for Metastatic Breast Cancer

NCT00618826•Barbara Ann Karmanos Cancer Institute

View on ClinicalTrials.gov

Summary

The purpose of this study is to look at a new chemotherapy schedule in metastatic breast cancer.

Detailed Description

The purpose of this study is to determine whether a new chemotherapy schedule using biweekly combination of paclitaxel (Taxol®), gemcitabine (Gemzar®) and Avastin would help to lessen in-between-cycle growth of resistant cells and to evaluate the toxicity of this therapy. Taxol is approved by the Food and Drug Administration (FDA) for use in metastatic breast and metastatic ovarian cancer but its use in this study is investigational. Gemzar is FDA approved for the use in breast, lung and pancreatic cancer but its use in this study is investigational. The Avastin being given in this study is commercially available, however, it has not been approved by FDA for use in metastatic breast cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient must be 18 years of age or older with histologically confirmed breast cancer and clinical evidence of metastatic disease.
•Patients must have measurable or non-measurable disease. X-rays, scans or physical examinations used to assess measurable disease must be performed within 28 days prior to registration. X-rays, scans or physical examinations to assess non-measurable disease must be completed within 42 days prior to registration. Patients with effusions or ascites as the only sites of disease are ineligible.
•Patients must meet the following requirements regarding prior and concurrent chemotherapy:Patients must not have received prior chemotherapy regimens for metastatic breast cancer. Patients may have received adjuvant/neoadjuvant chemotherapy, for a total of 3 prior regimens.
•Prior therapy with paclitaxel or docetaxel is allowed in the adjuvant or neoadjuvant setting, if given \> 6 months prior to registration.
•Patients must have \>14 days delay between the conclusion of any radiation and the start of gemcitabine, provided the acute effects of radiation treatment have resolved.
•Patients may have received any number of exogenous hormonal therapies and/or trastuzumab in the adjuvant, neoadjuvant or metastatic setting. Last dose of prior hormonal therapy at least 14 days prior to registration.
•Patients may receive concomitant bisphosphonate therapy for bone metastasis.
•Patients must have recovered from any prior surgery. Two weeks must have elapsed from the time of any minor surgery and 4 weeks of any major surgery.
•Patients must have adequate bone marrow reserve as evidenced by the following: ANC \> 1500/mcL, platelets \> 100, 000/mcL, and hemoglobin \> 9.0 gm/dL. These results must be obtained within 28 days prior to registration.
•Patients must have serum creatinine \< 1.5 mg/dL, obtained within 28 days prior to registration.
+3 more criteria

Exclusion Criteria

•Patients must not have tumors that carry HER-2 gene amplifications as determined by (i) fluorescence in situ hybridization (FISH) or (ii) overexpression of HER-2 protein 3+ level assessed by immunohistochemistry; or may have tumors that carry HER=2 gene amplification and have had disease progression while on trastuzumab. Patients who have previously been treated with trastuzumab must be off treatment at least 28 days prior to registration.
•Patients must not have CNS metastasis, leptomeningeal disease or lymphatic pulmonary metastases.
•Patients must not have had prior therapy with gemcitabine or bevacizumab.
•Patient must not have major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of treatment, anticipation of need for major surgical procedure during the course of the study.
•Patients must not have received radiation to \> 50% of the marrow-bearing bone.
•Patients must not have a history of significant symptomatic cardiac disease or left ventricular ejection fraction (LVEF) \< 50% of the institutional lower limit of normal (ILLN). An isotope cardiac scan (MUGA) and ECG must be obtained within 28 days.
•Patients must not have pr-existing clinically significant (Grade 2 or greater per CTCAE Version 3.0 motor or sensory neuropathy except for abnormalities due to cancer.
•Patients known to be HIV positive.
•Patients must not be nursing or pregnant. Men and women of reproductive potential must agree to use an effective contraceptive method.
•No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years.
+1 more criteria

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

November 1, 2006

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

April 14, 2017

Enrollment

ACTUAL participants

Conditions

Metastatic Breast Cancer

Interventions

Paclitaxel

DRUG

Gemcitabine

DRUG

Avastin

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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