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

NCT ID: NCT00618826

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2014-02-28

Brief 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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Period

Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.

Gemcitabine

Intervention Type: DRUG

Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.

Avastin

Intervention Type: DRUG

10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.

Interventions

Paclitaxel

Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.

Intervention Type: DRUG

Gemcitabine

Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.

Intervention Type: DRUG

Avastin

10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.

Intervention Type: DRUG

Eligibility Criteria

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.
• Urine Protein: creatinine ratio ≥ 1.0 at screening.
• Patients must have adequate liver function.
• Patients must have a Zubrod performance status of 0-1.

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 with uncontrolled hypertension are NOT eligible (BP>150/100).
• 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.
• Patients must not have had a Stroke or Myocardial Infarction in the past 6 months. Patients with unstable agina, significant peripheral vascular disease, history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within the last 6 months should be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Sayeh Lavasani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayed Lavasani, M.D.

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

2007-050

Identifier Type: OTHER

Identifier Source: secondary_id

B9E-US-I158

Identifier Type: OTHER

Identifier Source: secondary_id

AVF3734s

Identifier Type: OTHER

Identifier Source: secondary_id

2007-050

Identifier Type: -

Identifier Source: org_study_id