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AzTrials

Pancreatic CancerPhase 2NCT00111904

Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

A Phase 2 study testing paclitaxel-loaded polymeric micelle in people with Pancreatic Cancer, run by Theradex at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
paclitaxel-loaded polymeric micelle
How many people
43 participants
Where
5 sitesUnited States
Study dates
May 2005to Aug 2007
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 epithelial carcinoma of the pancreas
  • Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
  • 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 ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
  • No unstable or serious medical condition
  • No psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for pancreatic cancer
  • Prior fluorouracil as a radiosensitizer allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 6 weeks since prior radiotherapy for pancreatic cancer
  • Disease must have progressed after completion of radiotherapy

Surgery

  • More than 14 days since prior major surgery and recovered

Other

  • More than 30 days since prior investigational agents

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Southwest Regional Cancer Center - Central

    Austin, Texas, 78705

  • Florida Cancer Specialists - Bonita Springs

    Bonita Springs, Florida, 34135

  • Louisiana Oncology Associates - Lafayette

    Lafayette, Louisiana, 70506

  • St. Vincent's Comprehensive Cancer Center - Manhattan

    New York, New York, 10011

  • Midwest Cancer Research Group, Incorporated

    Skokie, Illinois, 60077

Other trials in United States

About this study

Official title: Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
  • Determine the best overall response rate and duration of response in patients treated with this drug.
  • Determine the overall survival of patients treated with this drug.
  • Determine the clinical benefit and safety of this drug in these patients.

OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Being tested
paclitaxel-loaded polymeric micelle
Keywords
stage III pancreatic cancer, 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.

  • paclitaxel-loaded polymeric micelleDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

  2. Time to treatment failure

  3. Best overall response rate

  4. Overall survival

  5. Clinical benefit

  6. Safety

Timeline

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

  1. First posted27 May 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionAug 2007

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
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111904
Sponsor's protocol ID
CDR0000433513
Other IDs
TARGET-S04-10485, WIRB-20050099
Status last verified
Jun 2009
First submitted
26 May 2005
Last updated
14 Dec 2011
Results posted
No

Publications

  • Saif MW, Podoltsev NA, Rubin MS, Figueroa JA, Lee MY, Kwon J, Rowen E, Yu J, Kerr RO. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest. 2010 Feb;28(2):186-94. doi: 10.3109/07357900903179591.

    PubMed 19968498

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel-loaded polymeric micelle in people with Pancreatic Cancer, run by Theradex at 5 sites in United States.

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: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

What does the primary outcome measure?

Time to progression. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00111904, which also lists 1 linked publication.

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 14 Dec 2011.

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