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Completed

NCT Number: NCT00562523

Sorafenib/Docetaxel Dose Escalation Trial

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tampa, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks

Primary outcomes

  1. To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib

    Time frame: 6 weeks

Secondary outcomes

  1. To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Amgen

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 22, 2007
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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