Clinical trial NCT00603356: Phase I Study of OSI-930 and Erlotinib in Cancer Tumors
Official title: A Phase 1 Dose Escalation Study of Daily Oral OSI-930 and Erlotinib (Tarceva) in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: GIST
Ovarian Cancer
Mesothelioma
Renal
Colorectal Cancer
Sarcoma
NSCLC
Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2008-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, dose escalation, safety study of OSI-930 and Erlotinib in cancer tumors.

Detailed description: Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose of OSI-930 and Erlotinib.

Patients may continue to receive OSI-930 and Erlotinib until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.

Eligibility criteria: Inclusion Criteria:

* Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
* Age greater than or equal to 18 years
* ECOG PS 0-2
* ANC greater than or equal to 1.5 x 10\^9/L
* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
* Creatinine less than or equal to 1.5 ULN
* Predicted life expectancy greater than or equal to 12 weeks
* Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed
* Prior tyrosine kinase inhibitor therapy is permitted
* Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
* Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
* Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)
* Prior surgery is permitted, provided that wound healing has occurred prior to registration
* Patients must use proactive effective contraceptive measures throughout the study
* Provide written informed consent
* Accessible for repeat dosing and follow-up
* Adequate hematopoietic, hepatic, and renal function

Exclusion Criteria:

* Significant cardiac disease unless well controlled
* Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
* Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
* History of unacceptable toxicity with previous EGFR inhibitor therapy
* History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
* Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
* Pregnant or breast-feeding females
* Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days
* History of allergic reaction attributed to a similar compound as study drug
* GI abnormalities including inability to take oral medications, required for IV alimentation
* Clinically significant ophthalmologic abnormalities

Primary outcomes:
measure: Determine the maximum tolerated dose (MTD), evaluate the pharmacokinetic profiles
timeFrame: 18 months
Secondary outcomes:
measure: Safety, evaluate pharmacodynamic relationships
timeFrame: 18 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
Study officials:
References: