Clinical trial NCT01494012: Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
Official title: A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Malignant Tumor of Peritoneum
Stage IV Ovarian Epithelial Cancer
Stage IV Ovarian Germ Cell Tumor
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)/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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor response to SBRT as assessed by FDG-PET/CT
timeFrame: At 3 months
measure: The rate of grade 3 or greater non-hematologic acute toxicity as graded by the CTCAE v. 4.0
timeFrame: 4-6 weeks, and up to 3 months after treatment
Secondary outcomes:
measure: Measure CA-125 level
timeFrame: At baseline; 6 weeks; and 3, 6, and 12 months
measure: FACT-Ovarian Symptom Index
timeFrame: At baseline; 6 weeks; and 3, 6, and 12 months
measure: Late toxicity and non-grade 3 or greater acute toxicity following SBRT
timeFrame: At 6 weeks; 3, 6, 12, 18 and 24 months
measure: Local control
timeFrame: Up to 5 years
measure: Progression-free survival
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Elizabeth Kidd
role: PRINCIPAL_INVESTIGATOR
References: