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

Sponsor

Herbert Hurwitz (Other)

Overall Status

Completed

CT.gov ID

NCT00849550

Collaborator

Roche-Genentech (Industry), Novartis (Industry)

Enrollment

Locations

Arm

Duration (Months)

10.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific Cancer	Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XELOX-A-Ev	Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral

Arm

Intervention/Treatment

Experimental: XELOX-A-Ev

Drug: capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev)

bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral

Outcome Measures

Primary Outcome Measures

To determine the MTD/RPTD of capecitabine/oxaliplatin/bevacizumab/everolimus (XELOX-A-Ev) for subjects with advanced solid tumors. [End of treatment phase]

Secondary Outcome Measures

Describe dose-limiting and non-dose-limiting toxicities [End of treatment phase]
preliminarily investigate the response rate and PFS [from response to progression]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ingalls Cancer Research Center	Harvey	Illinois	United States	60426
2	Duke University Medical Center	Durham	North Carolina	United States	27710
3	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203