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

This study has been completed.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
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)
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Colorectal Cancer
Intervention  Drug: epothilone D
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  October 2003
Completion Date
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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00077259
Organization ID CDR0000350080
Secondary IDs †† MSKCC-03113, ROCHE-NO17320
Study Sponsor  Memorial Sloan-Kettering Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Leonard B. Saltz, MD     Memorial Sloan-Kettering Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2005
First Received Date  February 10, 2004
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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