Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Vanderbilt University
Information provided by (Responsible Party):
Daniel Cho, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00782275
First received: October 29, 2008
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

The purpose of this research study is to find out the effects (good and bad) the study treatment has on participants and their cancer. Temsirolimus has been approved by the Food and Drug Administration (FDA) in the treatment of renal cell carcinoma. Avastin has been approved by the FDA for other types of cancers but not renal cell carcinoma.


Condition Intervention Phase
Renal Cell Carcinoma
Kidney Cancer
Drug: avastin
Drug: temsirolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Estimate the median progression-free survival in patients with metastatic RCC who have progressed on VEGF-targeted tyrosine kinase treated with avastin and temsirolimus [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the objective response rate for the combination of avastin and temsirolimus following TKI failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To estimate the median overall survival for patients treated with avastin and temsirolimus following TKI failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: January 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
This is a single-arm study. All patients will receive bevacizumab and temsirolimus.
Drug: avastin
Given intravenously on days 1 and 15
Drug: temsirolimus
Given intravenously on days 1, 8, 15, and 22

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 allowed
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782275

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Tennessee
Vanderbilt Univeristy Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Genentech
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Vanderbilt University
Investigators
Principal Investigator: Daniel Cho, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Daniel Cho, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00782275     History of Changes
Other Study ID Numbers: 08-184
Study First Received: October 29, 2008
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
RCC
avastin
temsirolimus

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sirolimus
Everolimus
Bevacizumab
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 15, 2014