DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024401
First received: September 13, 2001
Last updated: July 23, 2008
Last verified: June 2002
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: DHA-paclitaxel
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum

Resource links provided by NLM:


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

Study Start Date: May 2001
Detailed Description:

OBJECTIVES: I. Determine the objective tumor response rate, duration of response, and time to disease progression in patients with metastatic colorectal cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at end of study treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-50 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 cancer of the colon or rectum Clinical evidence of metastatic disease Failed 1 prior chemotherapy regimen for metastatic disease Measurable disease No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled ventricular arrhythmia No myocardial infarction within the past 3 months No superior vena cava syndrome Neurologic: No peripheral neuropathy greater than grade 1 No uncontrolled major seizure disorder No spinal cord compression Other: No unstable or serious concurrent medical condition No concurrent serious infection requiring parenteral therapy No other prior malignancy except: Curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix OR Other cancer curatively treated with surgery alone that has not recurred for more than 5 years No psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen for metastatic disease No prior taxanes At least 28 days since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 28 days since prior large-field radiotherapy and recovered No concurrent radiotherapy Surgery: At least 14 days since prior major surgery and recovered

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024401

Locations
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85712-2254
United States, District of Columbia
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
Sponsors and Collaborators
Theradex
Investigators
Study Chair: Ross C. Donehower, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024401     History of Changes
Other Study ID Numbers: CDR0000068929, THERADEX-P01-00-01, ABCCC-010505, PROTARGA-P01-00-01
Study First Received: September 13, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014