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

Herbert Hurwitz

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00849550

Pro00015605

4265 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

XELOX-A-Ev

Experimental group

Treatment:

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