Advertisement

Topics

Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer

2014-08-27 03:55:07 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and docetaxel by making the tumor cells more sensitive to the drugs.

PURPOSE: This phase I/II trial is studying the side effects and best dose of oblimersen when given together with doxorubicin and docetaxel and to see how well they work in treating women with metastatic or locally advanced breast cancer.

Description

OBJECTIVES:

Phase I (completed as of 8/16/04):

- Determine the pharmacokinetics of oblimersen, doxorubicin, and docetaxel in patients with metastatic or locally advanced breast cancer.

- Determine the maximum tolerated dose (MTD) of oblimersen in combination with doxorubicin and docetaxel in these patients.

- Determine the safety of this regimen in these patients.

Phase II:

- Determine the therapeutic efficacy of this regimen at the MTD of oblimersen in a neoadjuvant setting, in terms of pathologic complete response rate, in patients with locally advanced breast cancer.

- Determine the clinical and imaging response in the breast and axillary lymph nodes of patients treated with this regimen.

- Determine the disease-free survival of patients treated with this regimen.

- Determine the role of Bcl-2 expression as a predictor of response to this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of oblimersen.

- Phase I (phase I completed as of 8/16/04): Patients receive oblimersen IV continuously on days 1-6 interrupted only to administer doxorubicin IV over 15 minutes and docetaxel IV over 60 minutes on day 6. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 7-13 or pegfilgrastim SC on day 7. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

- Phase II: Patients receive doxorubicin, docetaxel, G-CSF or pegfilgrastim, and oblimersen at the MTD as in phase I.

Patients with resectable tumors after 6 courses undergo surgical resection.

Patients are followed every 3-6 months for 5 years.

PROJECTED ACCRUAL: A total of 69 patients (9 patients for phase I [phase I portion of the study completed as of 8/16/04] and 60 patients for phase II) will be accrued for this study within 2 years.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

Filgrastim, Oblimersen Sodium, Pegfilgrastim, Docetaxel, Doxorubicin Hydrochloride, Conventional Surgery, Neoadjuvant Therapy

Location

M.D. Anderson Cancer Center at University of Texas
Houston
Texas
United States
77030-4009

Status

Completed

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:07-0400

Clinical Trials [3030 Associated Clinical Trials listed on BioPortfolio]

Oblimersen and Doxorubicin in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

RATIONALE: Drugs used in chemotherapy such as doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of dox...

Docetaxel, Gemcitabine, and Filgrastim (G-CSF) or Pegfilgrastim in Treating Patients With Advanced, Persistent, or Recurrent Uterine Leiomyosarcoma

RATIONALE: Drugs used in chemotherapy, such as docetaxel and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...

Intermittent G-CSF in Patients With Breast Cancer Receiving Adjuvant Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)

To compare the efficacy and safety of Day 2 (D2) once a cycle pegfilgrastim with Intermittent Every Other Days of 5 Shot (D3-11) filgrastim in early breast cancer patients treated with adj...

Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docet...

Docetaxel With or Without Oblimersen in Treating Patients With Hormone-Refractory Adenocarcinoma (Cancer) of the Prostate

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of...

PubMed Articles [5654 Associated PubMed Articles listed on BioPortfolio]

Effect of Pegfilgrastim Primary Prophylactic Administration on Relative Dose Intensity(RDI)in Postoperative Adjuvant Chemotherapy(TC Therapy)for Breast Cancer - A Single-Center, Retrospective Study.

This study assessed the effect of pegfilgrastim in patients with early stage breast cancer who were receiving docetaxel and cyclophosphamide(TC)therapy(75mg/m / 2 docetaxel plus 600 mg/m2 cyclophospha...

Comparing granulocyte colony-stimulating factor filgrastim and pegfilgrastim to its biosimilars in terms of efficacy and safety: A meta-analysis of randomised clinical trials in breast cancer patients.

Granulocyte colony-stimulating factors (G-CSFs) are widely used to prevent neutropenia in cancer patients undergoing myelosuppressive chemotherapy. Several biosimilar medicines of G-CSF are now availa...

Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil or Caelyx in advanced ovarian cancer.

To compare the pharmacokinetic bioequivalence and safety of a generic pegylated liposomal doxorubicin formulation (SPIL DXR hydrochloride liposome injection) with that of the reference products, Caely...

A randomised phase II trial of docetaxel versus docetaxel plus carboplatin in patients with castration-resistant prostate cancer who have progressed after response to prior docetaxel chemotherapy: The RECARDO trial.

Docetaxel is standard first-line chemotherapy for patients with metastatic castration-resistant prostate carcinoma (mCRPC). Docetaxel re-challenge has never been tested in a prospective randomised con...

An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth factor, in breast cancer.

This randomized, open-label, active-controlled study investigated the safety and efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid growth factor, versus pegfilgrastim i...

Medical and Biotech [MESH] Definitions

Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.

Therapeutic practices which are not currently considered an integral part of conventional allopathic medical practice. They may lack biomedical explanations but as they become better researched some (PHYSICAL THERAPY MODALITIES; DIET; ACUPUNCTURE) become widely accepted whereas others (humors, radium therapy) quietly fade away, yet are important historical footnotes. Therapies are termed as Complementary when used in addition to conventional treatments and as Alternative when used instead of conventional treatment.

A voltage-gated sodium channel subtype that mediates the sodium ion PERMEABILITY of CARDIOMYOCYTES. Defects in the SCN5A gene, which codes for the alpha subunit of this sodium channel, are associated with a variety of CARDIAC DISEASES that result from loss of sodium channel function.

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 "Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

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...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial