Recurrent Ovarian Epithelial Cancer Clinical Trial
Official title:
A Phase I Study Evaluating the Efficacy and Toxicity of Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00390234 -
Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
|
Phase 2 | |
| Terminated |
NCT00091195 -
Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer
|
Phase 2 | |
| Completed |
NCT00096395 -
Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT00026091 -
Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer
|
Phase 2 | |
| Terminated |
NCT01962948 -
Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
| Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A | |
| Completed |
NCT00093496 -
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
|
Phase 2 | |
| Completed |
NCT00275028 -
AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
|
Phase 2 | |
| Completed |
NCT00132067 -
Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
|
Phase 2 | |
| Completed |
NCT00006942 -
Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 | |
| Completed |
NCT00004032 -
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT00023712 -
Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
|
Phase 2 | |
| Completed |
NCT02046421 -
Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 1 | |
| Terminated |
NCT01249443 -
Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection
|
Phase 1 | |
| Completed |
NCT00028535 -
Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
|
Phase 1 | |
| Completed |
NCT01747798 -
Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Early Phase 1 | |
| Withdrawn |
NCT01558778 -
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
|
N/A | |
| Completed |
NCT01652794 -
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
|
Phase 1 |