Clinical trial · Interventional
Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors
A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors
NCT00077454CI-TRIAL-00010620completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Previously Treated Childhood Rhabdomyosarcoma | Childhood Rhabdomyosarcoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Brain Tumor | Childhood Brain Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Childhood Cerebellar Astrocytoma | Childhood Cerebellar Astrocytoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Cerebral Astrocytoma | Childhood Cerebral Astrocytoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Ependymoma | Childhood Ependymoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Malignant Germ Cell Tumor | Childhood Malignant Germ Cell Tumor | CURATED_BROADER | 0.78 |
| Recurrent Childhood Medulloblastoma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (erlotinib hydrochloride, temozolomide)
- description
- 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.
- interventionNames
- Drug: erlotinib hydrochloride
- Drug: temozolomide
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Dose-limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- timeFrame
- 56 days (2 courses)
- measure
- Maximum-tolerated dose (MTD) based on the incidence of DLT as assessed by NCI CTCAE version 3.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * Bilirubin \< 1.5 times upper limit of normal (ULN) * ALT \< 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min * Creatinine based on age as follows: * ≤ 0.8 mg/dL for patients age 5 and under * ≤ 1.0 mg/dL for patients 6 to 10 * ≤ 1.2 mg/dL for patients 11 to 15 * ≤ 1.5 mg/dL for patients age 15 to 21 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow tablets (for patients in part 2 only) * No uncontrolled infection * Recovered from all prior immunotherapy * At least 7 days since prior biologic therapy * At least 3 months since prior stem cell transplantation and no evidence of active graft-versus-host disease * More than 1 week since prior growth factors * No concurrent prophylactic growth factor therapy * No concurrent immunotherapy * No concurrent biologic therapy * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent systemic corticosteroids except for treatment of increased intracranial pressure or symptomatic tumor edema in patients with CNS tumors * No concurrent steroids as an antiemetic * Concurrent dexamethasone for patients with CNS tumors allowed provided patient has been on a stable or decreasing dose for at least 1 week before study entry * Recovered from all prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 weeks since prior substantial bone marrow irradiation * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to 50% or more of the pelvis * At least 8 weeks since prior standard-fraction radiotherapy for patients with recurrent brain tumors unless there is biopsy proof of recurrent tumor * Prior radiosurgery within the past 9 months allowed provided there is documentation of progressive disease by biopsy, positron-emission tomography (PET) scan, or MR spectroscopy * No concurrent radiotherapy * More than 1 week since prior CYP3A4 inhibitors * More than 4 weeks since prior CYP3A4 inducers * More than 5 days since prior proton-pump inhibitors * More than 2 days since prior H\_2 blockers * No prior erlotinib * No concurrent enzyme-inducing anticonvulsants * No concurrent proton-pump inhibitors * No concurrent H2 blockers * No other concurrent investigational agents * Concurrent antacids allowed provided the antacid is not administered 2 hours before, during, and 2 hours after erlotinib administration
References
Publications (0)
Data not yet available
No reference posted for this study.