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

NCT00849550 | Completed Phase 1 DMC

• 2 other identifiers: Pro000156054265
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific; Cancer

Keywords

Advanced Solid Tumors; Cancer; Capecitabine; XELOX; Neoplasms; Oxaliplatin; Bevacizumab; RAD001

Outcome Measures

Primary Outcomes (1)

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

  End of treatment phase

Secondary Outcomes (2)

• Describe dose-limiting and non-dose-limiting toxicities

  End of treatment phase

• preliminarily investigate the response rate and PFS

  from response to progression

Study Arms (1)

XELOX-A-Ev

EXPERIMENTAL

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

Interventions

capecitabine/oxaliplatin/bevacizumab/RAD001 (XELOX-A-Ev) DRUG

bevacizumab IV, capecitabine oral, oxaliplatin IV, RAD001 oral

XELOX-A-Ev

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herbert Hurwitz: lead
• Roche-Genentech: collaborator
• Novartis: collaborator

Study Sites (3)

Ingalls Cancer Research Center

Harvey, Illinois, 60426, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Herbert Hurwitz, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2009
• First Posted: February 24, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 24, 2012

Record last verified: 2012-12

Locations

US (3)