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


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific, Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

End of treatment phase

Safety Issue:

Yes

Principal Investigator

Herbert Hurwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

Pro00015605

NCT ID:

NCT00849550

Start Date:

July 2009

Completion Date:

December 2012

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Cancer
  • Advanced Solid Tumors
  • Cancer
  • Capecitabine
  • XELOX
  • Neoplasms
  • Oxaliplatin
  • Bevacizumab
  • RAD001
  • Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Sarah Cannon Research InstituteNashville, Tennessee  37203
Ingalls Cancer Research CenterHarvey, Illinois  60426