NCT00077259

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

11 months

First QC Date

February 10, 2004

Last Update Submit

January 15, 2013

Conditions

Colorectal Cancer

Keywords

recurrent colon cancerrecurrent rectal cancerstage III colon cancerstage III rectal cancerstage IV colon cancerstage IV rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Interventions

epothilone DDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

desoxyepothilone B

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Leonard B. Saltz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2004

First Posted

February 11, 2004

Study Start

October 1, 2003

Primary Completion

September 1, 2004

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)