NCT00077454

Brief Summary

This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at 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

February 1, 2004

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

3.6 years

First QC Date

February 10, 2004

Last Update Submit

June 4, 2013

Conditions

Previously Treated Childhood RhabdomyosarcomaRecurrent Childhood Brain TumorRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Malignant Germ Cell TumorRecurrent Childhood MedulloblastomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent NeuroblastomaRecurrent Osteosarcoma

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    56 days (2 courses)

  • Maximum-tolerated dose (MTD) based on the incidence of DLT as assessed by NCI CTCAE version 3.0

    56 days (2 courses)

  • Pharmacokinetics of erlotinib hydrochloride

    At baseline and at 0.5, 1, 2, 4, 6, 8, and 24 hours of course 1

Study Arms (1)

Treatment (erlotinib hydrochloride, temozolomide)

EXPERIMENTAL

Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochlorideDrug: temozolomideOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

erlotinib hydrochlorideDRUG

Given orally (PO)

Also known as: CP-358,774, erlotinib, OSI-774
Treatment (erlotinib hydrochloride, temozolomide)
temozolomideDRUG

Given PO

Also known as: SCH 52365, Temodal, Temodar, TMZ
Treatment (erlotinib hydrochloride, temozolomide)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (erlotinib hydrochloride, temozolomide)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (erlotinib hydrochloride, temozolomide)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • One of the following histologically confirmed solid tumors:
  • Brain tumors
  • Osteogenic sarcoma
  • Rhabdomyosarcoma
  • Soft tissue sarcoma (excluding Ewing's sarcoma)
  • Neuroblastoma
  • Germ cell tumors
  • Recurrent or refractory disease
  • No known curative therapy exists
  • Performance status - Karnofsky 50-100% (for patients age 11 to 21)
  • Performance status - Lansky 50-100% (for patients age 10 and under)
  • At least 8 weeks
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3 (transfusion independent\*)
  • Hemoglobin \> 8.0 g/dL (transfusion allowed)
  • +44 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

AstrocytomaFamilial ependymomaMedulloblastomaNeuroblastomaOsteosarcoma

Interventions

Erlotinib HydrochlorideTemozolomide

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal Tumors, PrimitiveNeuroectodermal Tumors, Primitive, PeripheralNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcoma

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Regina Jakacki

    COG Phase I Consortium

    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

February 10, 2004

First Posted

February 12, 2004

Study Start

February 1, 2004

Primary Completion

September 1, 2007

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)