NCT00042809

Brief Summary

Phase I trial to study the effectiveness of combining erlotinib and trastuzumab with paclitaxel in treating patients who have advanced solid tumors. Biological therapies such as erlotinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and trastuzumab with paclitaxel may kill more tumor cells

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

May 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

5.6 years

First QC Date

August 5, 2002

Last Update Submit

January 23, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • Maximally tolerated dose (MTD), graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0

    Up to day 28

  • Response rates, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)

    Up to 6 years

Secondary Outcomes (1)

  • Incidence of adverse events, graded according to the NCI CTC v2.0

    Up to 30 days after last study treatment

Study Arms (1)

Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)

EXPERIMENTAL

See detailed description.

Drug: paclitaxelBiological: trastuzumabDrug: erlotinib hydrochlorideOther: laboratory biomarker analysisOther: pharmacological study

Interventions

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)
trastuzumabBIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)
erlotinib hydrochlorideDRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (paclitaxel, trastuzumab, erlotinib hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed metastatic solid tumor for which there are no effective standard treatment options
  • HER2 positive (1+ to 3+)
  • Tumor has a high likelihood of expressing epidermal growth factor receptor (EGFR)
  • No evidence of leptomeningeal disease or brain metastases unless previously treated, currently asymptomatic, and off both antiepileptics and dexamethasone
  • Patients with treated brain metastases are eligible if they are without any clinical change in their brain disease status for at least 4 weeks after whole brain irradiation
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver has tumor involvement)
  • Creatinine normal
  • Creatinine clearance at least 60 mL/min
  • LVEF more than 50% by radionuclide ventriculogram or MUGA scan
  • +30 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

PaclitaxelTaxesTrastuzumabErlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Muralidhar Beeram

    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

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2002

Primary Completion

December 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)