Clinical trial NCT00562523: Sorafenib/Docetaxel Dose Escalation Trial
Official title: A Phase I Dose Escalation Study With Sorafenib Administered Continuously in Combination With Docetaxel Administered Once Every Three Weeks in Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Cancer
Docetaxel
Sorafenib
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2007-11-22
Enrollment: 17
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: The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years
* Advanced histological or cytological documentation of cancer
* At least one evaluable lesion
* ECOG Performance Status of 0 or 1
* No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
* Life expectancy of at least 12 weeks
* No previous exposure to docetaxel or sorafenib
* Adequate bone marrow, liver and renal function as assessed by the following:

  * Hemoglobin greater than or equal to 9.0 g/dL
  * Absolute neutrophil count (ANC) greater than or equal to 2,500/mm3
  * Platelet count greater than or equal to 100,000/mm3 Hepatic
  * Total Bilirubin less than or equal to ULN
  * AST, ALT and Alkaline Phosphatase less than 1.5x ULN.
  * PT-INR/PTT less than 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or heparin will be allowed to participate provided that the INR less than 1.5. In addition, these patients must be monitored at appropriate intervals throughout study)
  * Serum creatinine less than or equal to 1.5 x upper limit of normal

Exclusion Criteria:

* Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
* Active clinically serious infections (\> Grade 2 NCI-CTCAE Version 3.0)
* Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
* Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Peripheral neuropathy \> Grade 1
* Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to screening
* Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
* Pregnant or breast feeding women

Primary outcomes:
measure: To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
timeFrame: 6 weeks
Secondary outcomes:
measure: To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: