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Pancreatic CancerPhase 2NCT00024375

DHA-Paclitaxel in Treating Patients With Metastatic Pancreatic Cancer

A Phase 2 study testing DHA-paclitaxel in people with Pancreatic Cancer, run by Theradex at 9 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
DHA-paclitaxel
How many people
Not given
Where
9 sitesin 4 countries
Study dates
Jun 2001to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

United States4 sites
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

Other trials in United States

Germany2 sites
  • Kliniken Essen - Mitte

    Essen, D-45136

  • Krankenhaus Nordwest

    Frankfurt, D-60488

Other trials in Germany

United Kingdom2 sites
  • Beatson Oncology Centre

    Glasgow, Scotland, G11 6NT

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

Other trials in United Kingdom

Netherlands1 site
  • Erasmus Medical Center

    Rotterdam, 3008 EA

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
DHA-paclitaxel
Keywords
recurrent pancreatic cancer, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHA-paclitaxelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024375
Sponsor's protocol ID
CDR0000068926
Other IDs
THERADEX-P01-00-03, PROTARGA-P01-00-03, VMRC-8770
Status last verified
Mar 2003
First submitted
13 Sep 2001
Last updated
18 Feb 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DHA-paclitaxel in people with Pancreatic Cancer, run by Theradex at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Germany, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.

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