Clinical trial · Interventional
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
A Phase I Study of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib; Tarceva) in Advanced Solid Tumors
NCT00126620CI-TRIAL-00018636completedPhase 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)
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib and erlotinib in treating patients with metastatic or unresectable solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OSI-774 erlotinib) and Bay 43-9006 (Sorafenib)
- description
- Sorafenib administered alone for a 1-week run-in period, and then both drugs e given together continuously, with every 28 days considered as a cycle. Three dose levels assessed.
- interventionNames
- Drug: erlotinib hydrochloride
- Drug: sorafenib tosylate
Primary outcomes (1)
- measure
- Maximum tolerated dose and recommended phase II dose
- timeFrame
- 28 days
Secondary outcomes (5)
- measure
- Pharmacodynamic outcomes
- timeFrame
- Pre study and cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Metastatic or unresectable disease * Standard curative or palliative measures do not exist OR are no longer effective * Measurable disease by radiography (for patients treated at the maximum tolerated dose \[MTD\] only) * Tumor accessible for serial biopsies (for patients treated at the MTD only) * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 12 weeks Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No bleeding diathesis or coagulopathy Hepatic * Bilirubin normal * AST and ALT ≤ 2.5 times ULN * PT INR ≤ 1.5 unless on full-dose warfarin Renal * Creatinine normal OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 140 mm Hg or diastolic BP \> 90 mm Hg despite medication) * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Ophthalmic * No abnormalities of the cornea, including any of the following: * Dry eye syndrome * Sjögren's syndrome * Congenital abnormalities (e.g., Fuch's dystrophy) * Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) * Abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Gastrointestinal * No active peptic ulcer disease that would impair the ability to swallow pills * No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to undergo serial biopsies, positron emission tomography, and CT scanning (for patients treated at the MTD only) * No ongoing or active infection * No significant traumatic injury within the past 3 weeks * No history of allergic reaction to drugs of similar chemical or biological composition to study drugs * No psychiatric illness or social situation that would preclude study compliance * No other condition that would impair the ability to swallow pills * No other uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic hematopoietic colony-stimulating factors Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy (except for low dose, non-myelosuppressive radiotherapy) and recovered Surgery * More than 3 weeks since prior major surgery * No prior surgical procedure affecting absorption Other * No prior sorafenib or erlotinib * No other prior agents targeting Raf, vascular endothelial growth factor (VEGF), VEGF receptor, or epidermal growth factor receptor * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital) * No concurrent CYP3A4 inducers (e.g., rifampin or Hypericum perforatum \[St. John's wort\]) * No other concurrent anticancer therapy * Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin) allowed provided PT INR \< 1.1 times upper limit of normal (ULN) * Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided both of the following criteria are met: * Patient has an in range INR (between 2-3) while on a stable-dose of oral anti-coagulant OR a stable-dose of low molecular weight heparin * No active bleeding OR pathological condition that would confer a high risk of bleeding (e.g., tumor involving a major vessel or known varices)
References
Publications (2)
- RESULTQuintela-Fandino M, Le Tourneau C, Duran I, Chen EX, Wang L, Tsao M, Bandarchi-Chamkhaleh B, Pham NA, Do T, MacLean M, Nayyar R, Tusche MW, Metser U, Wright JJ, Mak TW, Siu LL. Phase I combination of sorafenib and erlotinib therapy in solid tumors: safety, pharmacokinetic, and pharmacodynamic evaluation from an expansion cohort. Mol Cancer Ther. 2010 Mar;9(3):751-60. doi: 10.1158/1535-7163.MCT-09-0868. Epub 2010 Mar 2. PMID 20197396
- RESULTDuran I, Hotte SJ, Hirte H, Chen EX, MacLean M, Turner S, Duan L, Pond GR, Lathia C, Walsh S, Wright JJ, Dancey J, Siu LL. Phase I targeted combination trial of sorafenib and erlotinib in patients with advanced solid tumors. Clin Cancer Res. 2007 Aug 15;13(16):4849-57. doi: 10.1158/1078-0432.CCR-07-0382. PMID 17699864