Low-Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART) With Carboplatin and Docetaxel in Patients With Recurrent Ovarian Cancer
Conditions
Ovarian Cancer - Ovarian Carcinoma - Recurrent Ovarian Cancer - Recurrent Ovarian Carcinoma
Conditions: official terms
Carcinoma - Neoplasms, Glandular and Epithelial - Ovarian Neoplasms
Conditions: Keywords
Low Dose Fractionated Whole Abdominal Radiation Therapy, LDFWART, Carboplatin, Docetaxel, Ovarian Cancer, Ovarian Carcinoma
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Low Dose Fractionated Whole Abdominal Radiation Therapy Type: Radiation
Name: Carboplatin Type: Drug
Name: Docetaxel Type: Drug
Overall Status
Recruiting
Summary
The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and determine the recommended phase II dose of combining the effect of LDFWART following administration of Carboplatin and docetaxel for 6 cycles in patients with recurrent platinum-sensitive and - resistant ovarian cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Patients must have recurrent adenocarcinoma following first-line chemotherapy for metastatic disease. There is no limit on prior number of chemotherapy regimens. Patients who have received prior systemic docetaxel and platinum-based chemotherapy are eligible

- Patients must have > 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure.

- Patients must have a life expectancy of at least 6 months.

- Patients must have Karnofsky performance status (see Appendix F) of > 60 or Gynecology Oncology (GOG) performance status of < 2 (see www.GOG.org website).

- Age 18 - 80 years old

- Patients must have an adequate bone marrow, renal, and hepatic function:

- WBC: > 3,000 /mcl

- ANC: > 1,500 /mcl

- Platelets: > 100,000 /mcl

- Creatinine: < 2.0 mg/dcl

- Bilirubin: < 1.5x institutional normal value

- LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:< 3x institutional normal value.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees.

- Patients who have received prior radiation therapy to the head, neck, or lower extremities below the knees if greater than 3 years prior to study entry.

- Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid).

- Patients may not be receiving any other investigational agents within 4 weeks preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding the start of study treatment.

- Patients who have been diagnosed with another prior malignant tumor within 3 years of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the cervix.

- Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor) or carboplatin.

- Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection.

- Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate.

- Females of child-bearing potential. It is expected that ovarian cancer patients would have had a hysterectomy and/or oophorectomy as part of the original standard of care.

- Patients that are < 18 yrs. of age or > 80 yrs. of age
Location
University of Miami
Miami, Florida, United States
Status: Recruiting
Contact: University of Miami Sylvester Comprehensive Cancer Center - 866-574-5124 - sylvester@emergingmed.com
Start Date
May 2014
Sponsors
University of Miami
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page