Advertisement

Topics

Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer

2014-08-27 03:58:27 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine, and peripheral stem cell transplantation in treating patients who have stage II, stage III, or stage IV breast cancer.

Description

OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide, paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

filgrastim, amifostine trihydrate, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, peripheral blood stem cell transplantation

Location

Cancer Center and Beckman Research Institute, City of Hope
Duarte
California
United States
91010-3000

Status

Active, not recruiting

Source

City of Hope Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:27-0400

Clinical Trials [3564 Associated Clinical Trials listed on BioPortfolio]

Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effecti...

Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors

RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. PURPOSE: This phase II trial is studying how well amifostine work...

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-neg...

High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may...

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may...

PubMed Articles [3442 Associated PubMed Articles listed on BioPortfolio]

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase 3, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration (FDA) for commercial use in the United States, marketed as Zarxio®. This phase 3 ...

Spectrofluorimetric determination of acotiamide hydrochloride trihydrate in the presence of its oxidative degradation product.

Acotiamide hydrochloride trihydrate is a novel gastroprokinetic drug which has been recently approved for the treatment of patients with functional dyspepsia. This study presents the first reported to...

The early onset of peripheral neuropathy might be a robust predictor for time to treatment failure in patients with metastatic breast cancer receiving chemotherapy containing paclitaxel.

Paclitaxel plays a central role in chemotherapy for breast cancer. Peripheral neuropathy, a well-known toxicity with paclitaxel, may be of interest in predicting the efficacy of paclitaxel therapy for...

Safety and Efficacy of Low-dose Nanoparticle Albumin-bound Paclitaxel for HER2-negative Metastatic Breast Cancer.

Nab-paclitaxel (nab-PTX) is an albumin-bound paclitaxel formulation. Although nab-PTX has shown superior efficacy compared to conventional paclitaxel (PTX) in metastatic breast cancer (MBC), chemother...

Changes in volume and incidence of lymphedema during and after treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC) in patients with breast cancer.

The purposes of this study were to investigate the incidence of lymphedema in patients with breast cancer during and after adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC), t...

Medical and Biotech [MESH] Definitions

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.

Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.

A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.

More From BioPortfolio on "Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial