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A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

Phase 2
18 Years
Open (Enrolling)
Renal Cell Carcinoma, Kidney Cancer

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Trial Information

A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

- Participants will receive avastin on days 1 and 15 of each 28-day treatment cycle.
They will receive temsirolimus on days 1, 8, 15 and 22 of each cycle.

- During all treatment cycles, participants will have a physical exam, blood tests, and
urine test. An assessment of the tumor by CT (Computerized Tomography) scan will be
performed every 8 weeks.

- It is anticipated that participants will be in this research study for 5 years.

Inclusion Criteria:

- Histologically confirmed renal cell carcinoma in either primary or metastatic
lesions. Non-clear histology will be allowed.

- Disease progression on a VEGF-targeted tyrosine kinase inhibitor as the most recent
therapy or have experienced intolerable toxicity so as require discontinuation. Only
one prior VEGF-targeted tyrosine kinase inhibitor.

- Must be off of VEGF-targeted tyrosine kinase inhibitor for 2 weeks or greater.

- One measurable lesion which is not curable by standard radiation therapy or surgery.

- The enrolling site must agree to obtain paraffin-embedded tumor blocks or at least 10
unstained, paraffin-embedded slides for submission for correlative studies.

- 18 years of age or older

- ECOG Performance Status of 0 or 1

- Baseline laboratory values as outlined in the protocol

- Life expectancy of greater than 3 months

- No prior malignancy diagnosed within the past three years, other than superficial
basal cell and superficial squamous cell, or carcinoma in situ of the cervix.

Exclusion Criteria:

- Known CNS disease, except for treated brain metastases

- Previously treated with avastin or mTOR inhibitors

- Other then VEFG-targeted TKI, patients may only have had prior immunotherapy or
chemotherapy for stage IV disease

- History of allergic reaction to Chinese hamster ovary cell products, other
recombinant antibodies, or compounds of similar chemical or biologic composition to
avastin or temsirolimus

- History of bleeding diathesis or coagulopathy. Therapeutic anticoagulants are

- Patients with clinically significant cardiovascular disease

- Patients receiving enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer
such as rifampin or St. John's wort

- No serious non-healing wound, ulcer or bone fracture

- No uncontrolled intercurrent illness including , but not limited to, ongoing active
infection requiring parental antibiotics or psychiatric illness/social situations
that would limit compliance with study requirements

- HIV-positive receiving combination anti-retroviral therapy

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major surgical procedure during
the course of the study

- Core biopsy or other minor surgical procedure, excluding placement of vascular access
device, within 7 days prior to enrollment on study

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

- Known hypersensitivity to any component of avastin or temsirolimus

- Life expectancy of less than 12 weeks

- History of hemoptysis within 1 month prior to day 1

Type of Study:


Study Design:

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

Outcome Measure:

Estimate the median progression-free survival in patients with metastatic RCC who have progressed on VEGF-targeted tyrosine kinase treated with avastin and temsirolimus

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Daniel Cho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • Kidney Cancer
  • RCC
  • avastin
  • temsirolimus
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Vanderbilt Univeristy Medical CenterNashville, Tennessee  37232