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

Trial ID or NCT#

NCT01494012

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Elizabeth Kidd
Elizabeth Kidd
Radiation oncologist
Associate Professor of Radiation Oncology (Radiation Therapy)
Nelson Teng
Jonathan S. Berek, MD, MMSc
Jonathan S. Berek, MD, MMSc
Gynecologic oncologist
Laurie Kraus Lacob Professor

Contact us to find out if this trial is right for you.

Contact

Elizabeth A. Kidd
650-725-2174