Phase I Study of a Statin + Erlotinib for Advanced Solid Malignancies With Focus on Squamous Cell… (NCT00966472) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of a Statin + Erlotinib for Advanced Solid Malignancies With Focus on Squamous Cell Carcinomas and NSCLC
Canada24 participantsStarted 2009-03
Plain-language summary
The purpose of this study is to determine the recommended phase II dose (RP2D) of rosuvastatin that can be given in combination with standard erlotinib treatment in patients with advanced incurable squamous cell cancer and NSCLC.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Histologically or cytologically documented advanced and/or metastatic incurable tumor (especially squamous cell carcinoma or NSCLC).
* Clinically or radiologically documented (measurable or evaluable)disease.
* 18 years or older and less than 70 years of age.
* ECOG performance status: 0, 1 or 2
* No previous therapy with EGFR inhibitor (monoclonal antibody or TKI).
* Must have recovered from any treatment related toxicities prior to registration.
* Curative radiotherapy must be completed at least 3 months prior to registration
* Palliative radiotherapy is permitted providing a minimum of 14 days have elapsed between the end of radiotherapy and registration onto the study and patients have recovered from any acute toxic effects from radiation prior to registration.
* Previous surgery is permitted provided wound healing has occurred and at least 14 days have elapsed prior to registration if surgery was major.
* Adequate hematopoietic, hepatic and renal function defined as follows: hemoglobin \>= 90g/L, platelets \> 100 x 10\^9/L, bilirubin \<1.5 x ULN, ALT or AST \<1.5 x ULN, proteinuria \< grade 1, normal thyroid function (normal TSH or free T4 level after correction), serum creatinine institution normal limits or calculated creatinine clearance \> 60 mls/min (except for patients with cervical cancer who require a creatinine clearance of 72 mls/min.)
* Women must be post menopausal, surgically sterile or use two reliable forms of contraception. Women of…
What they're measuring
1
To determine the RPTD of rosuvastatin given orally daily x 3 weeks then 1 week off (28-day cycle) in combination with erlotinib given orally daily in patients with advanced solid tumors, especially squamous cell carcinomas and NSCLC.