Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT00572078
• Date of registration: 10/12/2007
• Primary sponsor: Indiana University
• Public title: Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors
• Scientific title: Phase I Dose-Escalation Drug-Interaction Study of Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors
• Date of first enrolment: July 2008
• Target sample size: 27
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00572078
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Daniela E Matei, MD
• Affiliation: Indiana University School of Medicine

• Name: Elena G Chiorean, MD
• Affiliation: Indiana University School of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histological or cytological diagnosis of a solid tumor with evidence of residual,
recurrent, or metastatic disease. Patients must be incurable by surgical or other
standard available therapy

- Measurable or evaluable disease; tumor size of = 2 cm on CT scan

- Patients may have received prior standard taxane therapy or anti-VEGF therapy, but
may not have progressed on both therapies. Progression on one type therapy (either
taxane or anti-VEGF) is allowed

Exclusion Criteria:

- History or presence of central nervous system (CNS) disease (i.e., primary brain
tumor, malignant seizures, CNS metastases or carcinomatous meningitis).

- Prior chemotherapy = 3 weeks prior to registration. Patients must have recovered from
all therapy-related toxicities

- Prior biologic or immunotherapy = 3 weeks prior to registration. Patients must have
recovered from all therapy-related toxicities

- Prior full pelvic field radiotherapy = 4 weeks or limited field radiotherapy = 2
weeks prior to randomization. Patients must have recovered to less than or equal to
grade 1 from all therapy-related toxicities except alopecia. The site of previous
radiotherapy should have evidence of progressive disease if this is the only site of
evaluable disease

- Major surgery (i.e., laparotomy) = 4 weeks prior to randomization or anticipation of
need for major surgical procedure during the course of the study

- Minor surgery = 2 weeks prior to randomization. Insertion of a vascular access
device is not considered major or minor surgery in this regard. Patients must have
recovered from all surgery-related toxicities

- Peripheral neuropathy with functional impairment = Common Terminology Criteria (CTC)
grade 2 neuropathy, regardless of causality

- Pleural effusion or ascites that causes respiratory compromise (= CTC grade 2
dyspnea)

- Concurrent severe and/or uncontrolled cardiac, vascular or infectious conditions (as
described in the protocol) which could compromise participation in the study

- Patients at risk of QT prolongation such as patients with congenital long QT syndrome
or with long corrected QT (QTc) at baseline (i.e. QTc greater than 450 msec in males,
and greater than 470 msec in females) will be excluded

- Lung carcinoma of squamous cell histology (mixed tumors will be categorized by the
predominant cell type unless small cell elements are present, in which case the
patient is ineligible; sputum cytology alone is not acceptable).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

SOLID TUMORS

Intervention(s)

Drug: Sorafenib

Primary Outcome(s)

To evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors. [Time Frame: baseline through end of treatment]

Secondary Outcome(s)

To evaluate pharmacodynamic changes a)in tumor vascular parameters and b)in plasma VEGF and soluble VEGF receptor levels, and correlate with clinical outcomes and sorafenib pharmacokinetic (PK) profile. [Time Frame: baseline through end of treatment]

To evaluate the pharmacokinetics of paclitaxel and sorafenib alone and in combination [Time Frame: baseline through end of treatment]

To evaluate variants in genes of paclitaxel drug-metabolism and drug-transporters P glycoprotein and correlate with PK profile for paclitaxel and with clinical outcomes [Time Frame: baseline through end of treatment]

Secondary ID(s)

0706-05 IUCRO-0171

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer

Genentech