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

Sponsor:	Memorial Sloan-Kettering Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077259

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: epothilone D	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Desoxyepothilone B Ixabepilone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2003

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum
Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination
Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease
No known CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 9 g/dL
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)
Alkaline phosphatase ≤ 5 times ULN

Renal

Creatinine ≤ 1.5 times ULN

Cardiovascular

No New York Heart Association class III or IV congestive heart failure
No QTc > 450 msec for males or > 470 msec for females
No personal or family history of congenital long QT syndrome

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
No pre-existing neuropathy grade 2 or greater
No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor
No infection requiring parenteral or oral anti-infective treatment
No altered mental status or psychiatric condition that would preclude giving informed consent
No other medical condition that would preclude study participation
No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen < 2 ng/mL

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent sargramostim (GM-CSF)
No concurrent routine prophylactic use of filgrastim (G-CSF)

Chemotherapy

See Disease Characteristics
At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

Not specified

Radiotherapy

At least 3 weeks since prior radiotherapy and recovered

Surgery

At least 3 weeks since prior surgery and recovered

Other

More than 3 weeks since prior investigational agents (therapeutic or diagnostic)
No other concurrent therapy for advanced or metastatic colorectal cancer
No other concurrent investigational drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077259

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Leonard B. Saltz, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000350080, MSKCC-03113, ROCHE-NO17320
Study First Received:	February 10, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00077259 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent colon cancer
recurrent rectal cancer
stage III colon cancer
stage III rectal cancer

stage IV colon cancer
stage IV rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Epothilones
Mitosis Modulators
Colonic Diseases
Antimitotic Agents
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Tubulin Modulators
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009