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

Stopped early · Phase 1

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

In brief

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.

Key facts

Study ID

NCT01494012

Run by

Stanford University

People needed

1

Starts

2012-04-01

Expected to finish

2012-09-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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