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

NCT ID: NCT00572078

Last Updated: 2017-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-23
• Study Completion Date: 2014-09-14

Brief Summary

The purpose of this study is 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.

Conditions

SOLID TUMORS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sorafenib, Bevacizumab & Paclitaxel

Paclitaxel is given as i.v infusion over 60 min on days 1, 8, 15 every 28 days. Sorafenib is given orally starting with cycle 1 day 2. Bevacizumab is given as i.v infusion on days 1 and 15 every 28 days.

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

Cohort 1 200 mg po BID D1-5; Cohort 2 200 mg po BID; Cohort 3 400 mg po BID D1-5 Cohort 4 400 mg po BID

Interventions

Sorafenib

Cohort 1 200 mg po BID D1-5; Cohort 2 200 mg po BID; Cohort 3 400 mg po BID D1-5 Cohort 4 400 mg po BID

Intervention Type: DRUG

Other Intervention Names

Bay 43-9006

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Safi Shahda

OTHER

Sponsor Role: lead

Responsible Party

Safi Shahda

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Safi G Shahda, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Cancer Center

Indianapolis, Indiana, United States

Countries

United States

References

Chiorean EG, Perkins SM, Strother RM, Younger A, Funke JM, Shahda SG, Hahn NM, Sandrasegaran K, Jones DR, Skaar TC, Schneider BP, Sweeney CJ, Matei DE. Phase I, Pharmacogenomic, Drug Interaction Study of Sorafenib and Bevacizumab in Combination with Paclitaxel in Patients with Advanced Refractory Solid Tumors. Mol Cancer Ther. 2020 Oct;19(10):2155-2162. doi: 10.1158/1535-7163.MCT-20-0277. Epub 2020 Aug 26.

Reference Type: DERIVED

PMID: 32847973 (View on PubMed)

Other Identifiers

0706-05 IUCRO-0171

Identifier Type: -

Identifier Source: org_study_id