NCT00078962

Brief Summary

This phase I trial is studying the side effects and best dose of GTI-2040 and gemcitabine in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by making tumor cells more sensitive to gemcitabine

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

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

January 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

March 8, 2004

Last Update Submit

January 23, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose (MTD) of GTI-2040 and gemcitabine hydrochloride, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v3.0

    Up to day 28

  • Adverse events, graded according to the NCI CTC v3.0

    Up to 2 years

Secondary Outcomes (3)

  • Levels of gemcitabine triphosphate (dFdCTP) in terms of pharmacokinetics of gemcitabine hydrochloride

    Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)

  • Levels of ribonucleotide reductase R2 and protein expression

    Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)

  • Levels of apoptotic markers and cell cycle regulatory proteins

    Days 1, 2, 8, and 15 (course 1), days 1, 2, 9, and 16 (course 2)

Study Arms (1)

Treatment (GTI-2040, gemcitabine hydrochloride)

EXPERIMENTAL

Patients receive GTI-2040 IV continuously on days 2-16 of course 1 and on days 1-16 of all subsequent courses and gemcitabine IV over 30 minutes on days 1, 8, and 15 of course 1 and on days 2, 9, and 16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of GTI-2040 and gemcitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose.

Biological: GTI-2040Drug: gemcitabine hydrochlorideOther: laboratory biomarker analysisOther: pharmacological study

Interventions

GTI-2040BIOLOGICAL

Given IV

Treatment (GTI-2040, gemcitabine hydrochloride)
gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Treatment (GTI-2040, gemcitabine hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (GTI-2040, gemcitabine hydrochloride)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (GTI-2040, gemcitabine hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed solid tumor
  • Metastatic or unresectable disease for which standard curative or palliative measures do not exist or are no longer effective
  • Measurable or evaluable disease
  • No known active or progressive brain metastases or primary brain tumors
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 12 weeks
  • Hemoglobin \> 9 g/dL
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if hepatic metastases are present)
  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • No symptomatic congestive heart failure
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

GTI2040Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Chris Takimoto

    Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2004

First Posted

March 9, 2004

Study Start

January 1, 2004

Primary Completion

November 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)