Clinical trial NCT00463060: Sutent and Radiation as Treatment for Limited Extent Metastatic Cancer
Official title: Phase I/II Study of Stereotactic Radiation Therapy and Concurrent and Adjuvant Sutent (SU11248) as Treatment for Oligometastatic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer
Keywords: erlotinib
celecoxib
radiation
progression-free survival
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-04-19
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cancer is the second leading cause of death in the United States, with approximately 90% of deaths resulting from patients with metastatic spread. Save for notable exceptions such as testicular cancer, chemotherapy alone cannot cure patients with metastases. Some patients with limited metastatic deposits (most commonly colon cancer spread to the liver) can be cured with surgery followed by chemotherapy. Therefore, some patients with metastases should be considered for aggressive local therapy (surgery and/or radiation).

Even though chemotherapy has improved significantly, patients treated with conventional chemotherapy and/or biologically targeted therapy are not cured of their disease. For the most common types of cancer, chemotherapy alone can shrink or stabilize tumors for an average of 6 months before the tumors regrow. Both chemotherapy and biologically targeted therapy have major limitations preventing cure of these patients.

Radiation therapy is an effective modality of treating cancer. Until recently, radiation for metastases was used only to relieve symptoms resulting from local tumor growth. Technological advances, including stereotactic radiotherapy, allow for radiation to be more precisely delivered to the tumor while sparing nearby normal organs. Stereotactic radiotherapy can completely eradicate local tumors with minimal side effects. Stereotactic radiotherapy has never been combined with drug therapy. Sutent is a new F.D.A. approved cancer therapy that targets tumor blood vessels. It is effective against two types of cancer that rarely respond to chemotherapy (GI stromal tumors and kidney cancer). We propose combining biologically targeted drug therapy with physically targeted stereotactic radiotherapy. Our goal is to determine if this is a safe regimen and the best method of combining these treatments. Ultimately, our goal is to cure some patients with previously incurable metastatic cancer with this combination.


Eligibility criteria: Inclusion Criteria:

* Zubrod Performance Scale 0-1
* Metastatic disease confirmed by biopsy or imaging
* 5 or fewer sites of metastatic disease on tumor staging (either CT chest/abdomen/pelvis plus bone scan or whole body FDG-PET)
* All tumors measure \< 6 cm
* Age \> 18
* Chemotherapy must be completed at least 2 weeks prior to radiation
* Signed informed consent
* Adequate bone marrow function, defined as follows;

  1. Platelets \> 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
  2. Absolute neutrophil count (ANC) \> 1,800 cells/mm3 based on CBC/differential obtained within 2 weeks prior to registration on study
  3. Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb \> 8.0 g/dt is acceptable.)

Exclusion Criteria:

* Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical carcinoma in situ, and other treated malignancies with no evidence of disease for at least 3 years
* Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
* Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
* Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
* Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
* Prior radiation to target area
* Patient may not be receiving any other investigational agents during radiotherapy.
* Prior history of non-inducible bleeding (12/16/09).
* Requirement for continuation of anticoagulation (defined as Coumadin, lovenox, heparin, plavix, aspirin, NSAIDs or similar drugs) during treatment (12/16/09)
* Under 18 years of age

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: 2 years
measure: Number of Participants With Particular Disease Status
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of Patients With Toxicity Grade 3 or Higher
timeFrame: 5 years
measure: Percentage of Patients With Local Control
timeFrame: 4 years
measure: Percentage of Patients With Distant Control
timeFrame: 4 weeks
measure: Quality of Life
timeFrame: 4-6 weeks after radiation therapy
measure: Number of Participants According Failure and Survival
timeFrame: 4 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Max Sung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kao J, Packer S, Vu HL, Schwartz ME, Sung MW, Stock RG, Lo YC, Huang D, Chen SH, Cesaretti JA. Phase 1 study of concurrent sunitinib and image-guided radiotherapy followed by maintenance sunitinib for patients with oligometastases: acute toxicity and preliminary response. Cancer. 2009 Aug 1;115(15):3571-80. doi: 10.1002/cncr.24412.
citation: Tong CC, Ko EC, Sung MW, Cesaretti JA, Stock RG, Packer SH, Forsythe K, Genden EM, Schwartz M, Lau KH, Galsky M, Ozao-Choy J, Chen SH, Kao J. Phase II trial of concurrent sunitinib and image-guided radiotherapy for oligometastases. PLoS One. 2012;7(6):e36979. doi: 10.1371/journal.pone.0036979. Epub 2012 Jun 27.
citation: Kao J, Chen CT, Tong CC, Packer SH, Schwartz M, Chen SH, Sung MW. Concurrent sunitinib and stereotactic body radiotherapy for patients with oligometastases: final report of a prospective clinical trial. Target Oncol. 2014 Jun;9(2):145-53. doi: 10.1007/s11523-013-0280-y. Epub 2013 May 10.