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Phase I Dose-Escalation Drug-Interaction Study of Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
SOLID TUMORS

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Trial Information

Phase I Dose-Escalation Drug-Interaction Study of Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

baseline through end of treatment

Safety Issue:

Yes

Principal Investigator

Elena G Chiorean, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

0706-05 IUCRO-0171

NCT ID:

NCT00572078

Start Date:

July 2008

Completion Date:

January 2014

Related Keywords:

  • Solid Tumors
  • solid tumor
  • Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265