Clinical trial NCT02083536: LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
Official title: A Phase I Study Using Low-Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART) As A Docetaxel Chemo-Potentiator for Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Ovarian Cancer
Ovarian Carcinoma
Recurrent Ovarian Cancer
Recurrent Ovarian Carcinoma
Keywords: Low Dose Fractionated Whole Abdominal Radiation Therapy
LDFWART
Docetaxel
Ovarian Cancer
Ovarian Carcinoma
Platinum-Resistant
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 docetaxel for 6 cycles in patients with recurrent platinum-resistant ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* 1. Patients must have platinum-resistant disease relapsing within 6 months or less from the date of their last cycle of initial adjuvant chemotherapy recurrent adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer 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
* 1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure.
* 2. Patients must have a life expectancy of at least 6 months.
* 3. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology (GOG) performance status of ≤ 2 (see www.GOG.org website).
* 4. Age 18 - 80 years old
* 5. Patients must have an adequate bone marrow, renal, and hepatic function:

  * 5.1 WBC: ≥ 3,000 /mcl
  * 5.2 ANC: ≥ 1,500 /mcl
  * 5.3 Platelets: ≥ 100,000 /mcl
  * 5.4 Creatinine: \< 2.0 mg/dcl
  * 5.5 Bilirubin: \< 1.5x institutional normal value
  * 5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:\< 3x institutional normal value.
* 6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* 1. Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees.
* 2. 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.
* 3. Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid).
* 4. 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.
* 5. 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.
* 6. Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor).
* 7. Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection.
* 8. Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate.
* 9. 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.
* 10. Patients that are \< 18 yrs. of age or \> 80 yrs. of age.

Primary outcomes:
measure: Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 years
measure: Recommended Phase II Dose of LDFWART
timeFrame: 3 years
Secondary outcomes:
measure: Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy
timeFrame: Up to 5 years
measure: The rate of Overall Survival in subjects receiving protocol therapy
timeFrame: Up to 5 years
measure: The rate of Progression-Free Survival in subjects receiving protocol therapy.
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Aaron H Wolfson, MD
role: PRINCIPAL_INVESTIGATOR
References: