NCT00111904

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2 pancreatic-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

December 14, 2011

Status Verified

June 1, 2009

Enrollment Period

2.3 years

First QC Date

May 26, 2005

Last Update Submit

December 13, 2011

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancerrecurrent pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (6)

  • Time to progression

  • Time to treatment failure

  • Best overall response rate

  • Overall survival

  • Clinical benefit

  • Safety

Interventions

paclitaxel-loaded polymeric micelleDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Florida Cancer Specialists - Bonita Springs

Bonita Springs, Florida, 34135, United States

Location

Midwest Cancer Research Group, Incorporated

Skokie, Illinois, 60077, United States

Location

Louisiana Oncology Associates - Lafayette

Lafayette, Louisiana, 70506, United States

Location

St. Vincent's Comprehensive Cancer Center - Manhattan

New York, New York, 10011, United States

Location

Southwest Regional Cancer Center - Central

Austin, Texas, 78705, United States

Location

Related Publications (1)

  • 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.

    PMID: 19968498RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

genexol-PM

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • John S. MacDonald, MD

    Beth Israel Comprehensive Cancer Center - West Side Campus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 26, 2005

First Posted

May 27, 2005

Study Start

May 1, 2005

Primary Completion

August 1, 2007

Last Updated

December 14, 2011

Record last verified: 2009-06

Locations

US(5)