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Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ross C. Donehower, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068929

NCT ID:

NCT00024401

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Arizona Oncology AssociatesTucson, Arizona  85712-2254