Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Epothilones

Desoxyepothilone B

Antineoplastic Agents, Immunological

Tubulin Modulators

Antimitotic Agents

≤100 mg/m\^2 intravenously (iv) on days 1, 8 and 15 once every 4 weeks

Epothilone D

4mg/kg iv loading dose, followed by 2mg/kg iv weekly

Herceptin

Clinical Trials

This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer. Epothilone D will be administered intravenously on days 1, 8 and 15 every 4 weeks at a dose not exceeding 100mg/m2. Herceptin will be administered intravenously on a weekly schedule; a 4mg/kg loading dose will be followed by a weekly maintenance dose of 2mg/kg. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

An Open-label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer

Hoffmann-La Roche

Symptoms and General Pathology

Digestive System Diseases

Recurrence

Carcinoma

Adenocarcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

epothilone D

Leonard B. Saltz, MD

RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer.

OBJECTIVES:

Primary

* Determine the antitumor activity of epothilone D as second-line treatment, in terms of objective response rate, in patients with advanced or metastatic refractory colorectal cancer.

Secondary

* Determine the safety of this drug in these patients.
* Determine the response duration in patients responding to treatment with this drug.
* Determine time to tumor progression and overall survival in patients treated with this drug.
* Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 19-69 patients will be accrued for this study.

Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer

A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Epothilone D (KOS-862)

Bristol-Myers Squibb

Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.

A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors

A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Naiyer Rizvi, MD

RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.

OBJECTIVES:

Primary

* Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy.

Secondary

* Determine the safety of this drug in these patients.
* Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug.
* Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment.
* Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.

Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer	NCT00337649	Breast Cancer	Epothilone D Herceptin	18 Years -	Hoffmann-La Roche
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer	NCT00337649	Breast Cancer	Epothilone D Herceptin	18 Years -	Hoffmann-La Roche
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer	NCT00077259	Colorectal Canc...	epothilone D	18 Years -	Memorial Sloan Kettering Cancer Center
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors	NCT00030173	Neoplasms	Epothilone D (K...	18 Years - 85 Years	Bristol-Myers Squibb
Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy	NCT00081107	Lung Cancer	epothilone D	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for epothilone d

Every month we try and update this database with for epothilone d cancer trials from around the world to help patients and their families find trials that might be right for them.
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