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

Stanford University

Status and phase

Terminated

Phase 1

Conditions

Stage IV Ovarian Germ Cell Tumor

Malignant Tumor of Peritoneum

Recurrent Ovarian Germ Cell Tumor

Recurrent Ovarian Epithelial Cancer

Stage IV Ovarian Epithelial Cancer

Treatments

Procedure: computed tomography

Drug: fludeoxyglucose F 18

Other: questionnaire administration

Radiation: stereotactic body radiation therapy

Procedure: positron emission tomography

Study type

Interventional

Funder types

Other

Identifiers

NCT01494012

NCI-2011-03652 (Registry Identifier)

SU-12072011-8791 (Other Identifier)

22550 (Other Identifier)

GYNOVA0021

Details and patient eligibility

About

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.

Full 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)/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.

Enrollment

1 patient

Sex

Female

Ages

18+ years old

Volunteers

No 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.