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Phase I Study With Sorafenib in Combination With Carboplatin and Paclitaxel to Evaluate the Safety and Pharmacokinetics of This Combination in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Phase I Study With Sorafenib in Combination With Carboplatin and Paclitaxel to Evaluate the Safety and Pharmacokinetics of This Combination in Patients With Solid Tumors

Inclusion Criteria:

- Age > or equal to 18 years

- Histological or cytological documentation of cancer, except non small cell lung

- ECOG Performance Status of 0 or 1

- Life expectancy of at least 12 weeks

- No more than two prior chemotherapy regimens

- Adequate bone marrow, liver and renal function as assessed by the following:

- Hemoglobin > or equal to 9.0 g/dL

- Absolute neutrophil count (ANC) > or equal to 1,500/mm3

- Platelet count > or equal to 100,000/mm3

- Total bilirubin < or equal to 1.25 times the ULN

- ALT and AST < or equal to 2.5 x ULN

- PT-INR/PTT < 1.5 x ULN (Patients who are being prophylactically anti coagulated
with an agent such as coumadin or low molecular weight heparin or
therapeutically anticoagulated with LMWH will be allowed to participate provided
that they meet these criteria; in addition, these patients must be monitored at
appropriate intervals throughout study)

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to the start of treatment.

- Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation, including the 30
day period after last study drug dosing. The investigator should advise the patient
regarding adequate means of contraception.

- Serum creatinine < or equal to 1.5 x upper limit of normal

- Ability to understand and willingness to sign a written informed consent. A signed
informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

- Clinically evident congestive heart failure > NYHA Class 2 (See Appendix 10.4)

- Serious cardiac arrhythmias (for example requiring anti-arrhythmics)

- Myocardial infarction or symptomatic coronary artery disease (severe or unstable
angina) within 6 months prior to screening

- Active clinically serious infections (> Grade 2 NCI-CTC)

- Patients with history of brain metastases are eligible as long as the metastasis has
been treated with either stereotactic or whole brain radiation, stereotactic
gamma-knife radiosurgery or neurosurgery, patient does not require ongoing treatment
with dexamethasone, the patient is not on anticoagulant therapy and whose
radiographic imaging is stable ≥ 4 weeks from start of treatment. Time from brain
metastasis treatment to first study treatment must meet the following criteria:

- Stereotactic or whole brain radiation, stereotactic gamma-knife radiosurgery ≥ 4
weeks from first study treatment

- Neurosurgery ≥ 24 weeks from first study treatment

- Brain biopsy ≥ 12 weeks from first study treatment

- History of organ allograft

- 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 > or equal to Grade 2

- Thrombotic or embolic events (such as transient ischemic attacks, myocardial
infarction, pulmonary embolus), within 6 months prior to Screening

- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first study

- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first study

- Evidence or history of bleeding diathesis or coagulopathy

- Serious, non-healing wound, ulcer, or bone fracture

- Patients undergoing renal dialysis

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
study treatment

- Previous cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma,
superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 3 years
prior to first study treatment

- Non small cell lung cancer

- Ongoing substance abuse, medical, psychological or social conditions that may
interfere with the patient's participation in the study or evaluation of the study

- Pregnant or breast-feeding patients.

- Known or suspected allergy to the investigational agent or any agent given in
association with this trial

- Any condition that is unstable or could jeopardize the safety of the patient and
their compliance in the study

- Any condition that impairs patient's ability to swallow whole pills

- Any malabsorption condition

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and pharmacokinetics of the three agents: sorafenib administered daily, without a break in dosing, in combination with carboplatin and paclitaxel, administered every 3 weeks

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

February 2009

Related Keywords:

  • Neoplasms
  • Chemotherapy
  • Solid Tumors
  • Sorafenib
  • Carboplatin
  • Paclitaxel
  • Neoplasms



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