Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

Study Overview
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Brief Summary
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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 cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Detailed Description
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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)/computed tomography (CT) 3 months after therapy. II. Determine the rate of grade 3 or greater non-hematologic acute toxicity from SBRT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. SECONDARY OBJECTIVES: I. Evaluate response to SBRT using cancer antigen-125 (CA-125) and symptom assessment using Functional Assessment of Cancer Therapy (FACT)-Ovarian Symptom Index (FOSI). II. Determine the rate of late and non-grade 3 acute toxicity using CTCAE version 4.0. III. Evaluate local control, progression-free survival, and overall survival following SBRT. OUTLINE: Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 weeks, 3, 6, 9, and 12 months, and then every 6 months for 4 years.

Official Title
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A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

Conditions
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Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Malignant Tumor of Peritoneum, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor

Intervention / Treatment
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* Radiation: stereotactic body radiation therapy
* Procedure: positron emission tomography
* Procedure: computed tomography
* Other: questionnaire administration
* Drug: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (SBRT)<br>Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease progression or unacceptable toxicity. | Radiation: stereotactic body radiation therapy<br>* Undergo SBRT<br>* Other names: stereotactic radiotherapy;Procedure: positron emission tomography<br>* Undergo FDG-PET/CT<br>* Other names: tomography, emission computed;Procedure: computed tomography<br>* Undergo FDG-PET/CT<br>* Other names: tomography, computed;Other: questionnaire administration<br>* Ancillary studies<br>Drug: fludeoxyglucose F 18<br>* Undergo FDG-PET/CT<br>* Other names: FDG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response to SBRT as assessed by FDG-PET/CT | FDG-PET response based on interpretation by nuclear medicine physician with measurement of the maximal standard uptake value (SUV) and identification of new sites of disease. Percentage of decreased SUVmax between the pre- and post-treatment FDG-PET/CT, evaluating means, medians, range and standard deviations. | At 3 months | 
| The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0 | Toxicity will be tabulated by type and grade. | 4-6 weeks, and up to 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure CA-125 level |  | At baseline; 6 weeks; and 3, 6, and 12 months | 
| FACT-Ovarian Symptom Index |  | At baseline; 6 weeks; and 3, 6, and 12 months | 
| Late toxicity and non-grade 3 or greater acute toxicity following SBRT |  | At 6 weeks; 3, 6, 12, 18 and 24 months | 
| Local control |  | Up to 5 years | 
| Progression-free survival |  | Up to 5 years | 
| Overall survival |  | Up to 5 years |