NCT00052689

Brief Summary

Randomized phase II trial to compare the effectiveness of bortezomib with or without gemcitabine in treating patients who have metastatic pancreatic cancer. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with gemcitabine may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

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

December 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

4.8 years

First QC Date

January 24, 2003

Last Update Submit

October 7, 2013

Conditions

Duct Cell Adenocarcinoma of the PancreasStage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

  • Confirmed tumor response (CR, PR) rate in 2 consecutive courses within 6 months (Arm I)

    An evaluable patient will be classified as a treatment 'success' if they have a confirmed tumor response (CR, PR). The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

    Up to 6 months

  • Proportion of patients alive at 6 months (Arm II)

    An evaluable patient will be classified a treatment 'success' if they are alive at 6 months. The proportion of successes will be estimated by the total number of evaluable patients. 95% confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

    At 6 months

Secondary Outcomes (3)

  • Survival time

    Time from randomization to death due to any cause, assessed up to 5 years

  • Time to disease progression

    Time from randomization to documentation of disease progression, assessed up to 5 years

  • Time to treatment failure

    Time from the date of randomization to the date at which the patient is removed from the treatment due to progression, toxicity, or refusal, assessed up to 5 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Patients with progressive disease crossover to arm II.

Drug: bortezomib

Arm II

EXPERIMENTAL

Patients receive bortezomib as in arm I and gemcitabine IV over 30 minutes on days 1 and 8.

Drug: bortezomibDrug: gemcitabine hydrochloride

Interventions

bortezomibDRUG

Given IV

Arm IArm II
gemcitabine hydrochlorideDRUG

Given IV

Arm II

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed metastatic ductal or undifferentiated adenocarcinoma consistent with a pancreatic primary for which no standard curative measures exist
  • No locally advanced disease only
  • No islet cell, acinar cell, or cystadenocarcinomas
  • Measurable disease
  • At least one lesion whose longest diameter can be accurately measured as 2 cm or greater by conventional techniques OR 1 cm or greater by spiral CT scan
  • A tumor lesion in a previously irradiated area allowed provided it is histologically confirmed disease with radiographic progression from a post-radiotherapy CT scan
  • No CNS metastasis
  • Performance status - ECOG 0-2
  • At least 3 months
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9.0 g/dL
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) (stents allowed)
  • AST no greater than 5 times ULN
  • PT and PTT no greater than ULN\*
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

BortezomibGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

Study Officials

  • Steven Alberts

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

December 1, 2002

Primary Completion

October 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)