Status:
TERMINATED
Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
Lead Sponsor:
Stanford University
Conditions:
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cance...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate response of platinum-resistant ovarian cancer to stereotactic body radiation therapy (SBRT) using fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/com...
Eligibility Criteria
Inclusion
- Patients must have persistent, metastatic, or recurrent platinum resistant or refractory ovarian or primary peritoneal cancer.
- No restriction on previous treatment regimens, but patients must be at least 2 weeks out from last chemotherapy or investigational agent.
- Patients must be \>= 18.
- Patients must have a life expectancy of at least 6 months.
- Patients must have KPS \>= 60.
- Patients must have acceptable organ and marrow function as defined below (within 2 weeks prior to radiotherapy):
- leukocytes \>=3,000/uL
- absolute neutrophil count \>=1,500uL
- platelets \>=100,000/uL
- total bilirubin within 1.5X normal institutional limits
- AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
- creatinine within normal institutional limits OR
- creatinine clearance \>=60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Patients must be willing to undergo a pre- and post-treatment FDG-PET/CT.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients should not have received radiation overlapping with the proposed treatment field.
- Patients cannot be receiving chemotherapy or other investigation agents from two weeks prior to radiation through undergoing their post-therapy FDG-PET/CT
- Patients cannot be pregnant or nursing.
- Patients cannot have disease \>= 8cm or greater than 3 regions of disease.
- Patients cannot have concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01494012
Start Date
April 1 2012
End Date
September 1 2012
Last Update
April 28 2017
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305