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DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024375
First received: September 13, 2001
Last updated: February 17, 2009
Last verified: March 2003
  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 pancreatic cancer.


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

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

Resource links provided by NLM:


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

Study Start Date: June 2001
Detailed Description:

OBJECTIVES:

  • Determine the tumor response rate, duration of response, and time to disease progression in patients with metastatic carcinoma of the pancreas treated with DHA-paclitaxel.
  • Determine the overall survival of patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.
  • 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 completion of treatment.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-50 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 carcinoma of the pancreas

    • Metastatic disease
  • Measurable disease

    • Lesions within a previously irradiated field are not considered measurable
  • No islet cell tumors, lymphoma, or sarcoma of the pancreas
  • 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/mm^3
  • Platelet count at least 100,000/mm^3

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 concurrent serious infection requiring parenteral therapy
  • No unstable or serious concurrent medical condition
  • 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 compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • No prior chemotherapy for metastatic disease
  • Prior adjuvant chemoradiotherapy allowed
  • At least 28 days since prior chemotherapy and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except megestrol

Radiotherapy:

  • See Disease Characteristics
  • Prior adjuvant chemoradiotherapy allowed
  • 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

Other:

  • No other concurrent anticancer therapy
  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: NCT00024375

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Germany
Kliniken Essen - Mitte
Essen, Germany, D-45136
Krankenhaus Nordwest
Frankfurt, Germany, D-60488
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3008 EA
United Kingdom
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
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: NCT00024375     History of Changes
Other Study ID Numbers: CDR0000068926, THERADEX-P01-00-03, PROTARGA-P01-00-03, VMRC-8770
Study First Received: September 13, 2001
Last Updated: February 17, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 24, 2014