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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epothilone D
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 10, 2004
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077259
Brief Title
Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epothilone D

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard B. Saltz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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