Sorafenib/ Carboplatin/ Paclitaxel in Patients With Solid Tumors

NCT00606125 | Completed Phase 1

• 1 other identifier: 11988
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to:

1. 1.Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
2. 2.Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
3. 3.To determine the safety of sorafenib.

Conditions

Neoplasms

Keywords

Chemotherapy; Solid Tumors; Sorafenib; Carboplatin; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• To determine the safety profile and pharmacokinetics of oral sorafenib daily in combination with every 3-weekly carboplatin and paclitaxel.

  2 years

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006)

Interventions

Nexavar (Sorafenib, BAY43-9006) DRUG

The purpose of this study is to: 1)evaluate how your body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin, 2) measure your blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and 3) to determine the safety of sorafenib.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> or equal to 18 years
• Histological or cytological documentation of cancer, except non small cell lung cancer
• 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

You may not qualify if:

• 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 treatment

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

New Haven, Connecticut, 06511-5991, United States

Location

Unknown Facility

San Antonio, Texas, 78229-3307, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 1, 2008
• Study Start: May 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: February 1, 2009
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

US (2)