NCT00320749

Brief Summary

The primary purpose of this study is to define the maximum tolerated dose of combination docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects will be measured in study participants. In addition, researchers will assess data about preliminary efficacy in patients with this treatment approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

2 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

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 19, 2015

Completed
Last Updated

June 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2.8 years

First QC Date

April 28, 2006

Results QC Date

September 15, 2015

Last Update Submit

May 25, 2016

Conditions

Pancreatic Cancer

Keywords

Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    MTD will be the dose at which 1 or fewer patients (≤ 1/6) experiences a DLT during the first or second cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing Dose Limiting Toxicities (DLT).

    Weekly up to 24 weeks

Secondary Outcomes (2)

  • Common Toxicities

    Weekly up to 24 weeks

  • Therapeutic Response

    every 8 weeks, up to 24 weeks

Study Arms (1)

capecitabine, docetaxel, gemcitabine

EXPERIMENTAL

Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.

Drug: CapecitabineDrug: DocetaxelDrug: Gemcitabine

Interventions

CapecitabineDRUG

Will be give on days 8-21

Also known as: Xeloda
capecitabine, docetaxel, gemcitabine
DocetaxelDRUG

Will be given on days 1 and 8,

Also known as: Taxotere
capecitabine, docetaxel, gemcitabine
GemcitabineDRUG

A fixed dose rate will be give on days 8 and 15.

Also known as: Gemzar
capecitabine, docetaxel, gemcitabine

Eligibility Criteria

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

You may qualify if:

  • adenocarcinoma of the pancreas
  • no prior chemo except adjuvant
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • peripheral neuropathy \</= Gr. 1

You may not qualify if:

  • Pregnant/lactating females
  • Uncontrolled heart disease, diabetes, psychiatric disorder
  • Therapeutic doses of Warfarin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Hill ME, Li X, Kim S, Campbell A, Culler K, Bloomston M, Zalupski M, Hejna G, Bekaii-Saab T. A phase I study of the biomodulation of capecitabine by docetaxel and gemcitabine (mGTX) in previously untreated patients with metastatic adenocarcinoma of the pancreas. Cancer Chemother Pharmacol. 2011 Mar;67(3):511-7. doi: 10.1007/s00280-010-1348-3. Epub 2010 May 12.

    PMID: 20461379RESULT

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CapecitabineDocetaxelGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Tanios Bekaii-Saab, M.D.
Organization
The Ohio State University Comprehensive Cancer Center
Tanios.Bekaii-Saab@osumc.edu
614-293-9863

Study Officials

  • Tanios Saab

    Ohio State University

    PRINCIPAL INVESTIGATOR

  • Tanios Saab, M.D.

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Start

December 1, 2005

Primary Completion

October 1, 2008

Study Completion

January 1, 2011

Last Updated

June 27, 2016

Results First Posted

October 19, 2015

Record last verified: 2016-05

Locations

US(2)