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

Sponsor

Stanford University (Other)

Overall Status

Terminated

CT.gov ID

NCT01494012

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Malignant Tumor of Peritoneum Stage IV Ovarian Epithelial Cancer Stage IV Ovarian Germ Cell Tumor	Radiation: stereotactic body radiation therapy Procedure: positron emission tomography Procedure: computed tomography Other: questionnaire administration Drug: fludeoxyglucose F 18	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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.
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:

Evaluate response to SBRT using cancer antigen-125 (CA-125) and symptom assessment using Functional Assessment of Cancer Therapy (FACT)-Ovarian Symptom Index (FOSI).
Determine the rate of late and non-grade 3 acute toxicity using CTCAE version 4.0.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (SBRT) 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 Undergo SBRT Other Names: SBRT stereotactic radiation therapy stereotactic radiotherapy Procedure: positron emission tomography Undergo FDG-PET/CT Other Names: FDG-PET PET PET scan tomography, emission computed Procedure: computed tomography Undergo FDG-PET/CT Other Names: tomography, computed Other: questionnaire administration Ancillary studies Drug: fludeoxyglucose F 18 Undergo FDG-PET/CT Other Names: 18FDG FDG

Arm

Intervention/Treatment

Experimental: Treatment (SBRT)

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

Undergo SBRT

Other Names:

SBRT

stereotactic radiation therapy

stereotactic radiotherapy

Procedure: positron emission tomography

Undergo FDG-PET/CT

Other Names:

FDG-PET

PET

PET scan

tomography, emission computed

Procedure: computed tomography

Undergo FDG-PET/CT

Other Names:

tomography, computed

Other: questionnaire administration

Ancillary studies

Drug: fludeoxyglucose F 18

Undergo FDG-PET/CT

Other Names:

18FDG

FDG

Outcome Measures

Primary Outcome Measures

Tumor response to SBRT as assessed by FDG-PET/CT [At 3 months]
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.
The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0 [4-6 weeks, and up to 3 months after treatment]
Toxicity will be tabulated by type and grade.

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.