Safety and Dosage Study of RAD001 (Everolimus) in Combination With Current Standard of Care to Treat Advanced Solid Tumors.

Cancer Clinical Trial

— COBRA  

Official title:

A Phase I Study of Capecitabine, Oxaliplatin, Bevacizumab, and RAD001 (XELOX-A-Ev) for Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849550
• Other study ID #: Pro00015605
• Secondary ID: 4265
• Status: Completed
• Phase: Phase 1
• First received: February 22, 2009
• Last updated: December 21, 2012
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if RAD001 (everolimus) helps improve the standard treatment of XELOX-A (bevacizumab, oxaliplatin, capecitabine) in advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be 18 years or older

• Must have a performance status of at least 70% (able to carry on most normal activities)

• Must have life expectancy of at least 3 months

• Must have adequate organ and marrow function as determined by lab tests

• Women of child-bearing potential and men must agree to use two forms of contraception

• Ability and willingness to sign a written informed consent document

• Histologically confirmed solid tumor malignancy that is metastatic or unresectable

Exclusion Criteria:

• Pregnant or breastfeeding and/or lactating women

• Patients who have received any other investigational agents within 28 days of the first day of study drug

• Patients with known CNS metastases

• History of other carcinomas within last 5 years (except non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer)

• Inadequately controlled hypertension

• Significant vascular disease

• Invasion or encasement of a major artery

• Evidence of bleeding diathesis or coagulopathy

• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to day 1 of study drug

• Serious illness or medical condition

• History of myocardial infarction, unstable angina, cardiac or other vascular stenting

• History of stroke

• HIV, Hepatitis C, Hepatitis B or other serious chronic infection

• Impairment of Gastrointestinal function or disease

• History of interstitial lung disease

• Patients who have had radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within 28 days of receiving study drug.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)
bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Ingalls Cancer Research Center	Harvey	Illinois
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Herbert Hurwitz	Novartis, Roche-Genentech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors.		End of treatment phase	Yes
Secondary	Describe dose-limiting and non-dose-limiting toxicities		End of treatment phase	Yes
Secondary	preliminarily investigate the response rate and PFS		from response to progression	Yes