LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Aaron Wolfson, University of Miami
ClinicalTrials.gov Identifier:
NCT02083536
First received: March 6, 2014
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Ovarian Cancer
Ovarian Carcinoma
Recurrent Ovarian Cancer
Recurrent Ovarian Carcinoma
Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of subjects experiencing adverse events after receiving protocol therapy.

  • Recommended Phase II Dose of LDFWART [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.


Secondary Outcome Measures:
  • Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Number of subjects experiencing complete response (CR) or partial response (PR) according to RECIST Criteria Version 1.1

  • The rate of Overall Survival in subjects receiving protocol therapy [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Observed length of life from start of treatment to cause of death

  • The rate of Progression-Free Survival in subjects receiving protocol therapy. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Length of time from start of treatment to the time of documented disease progression in study subjects


Estimated Enrollment: 12
Study Start Date: May 2014
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDFWART + Docetaxel
This study has 6 treatment cycles given at 3 weeks intervals ± 3 days. A cycle is defined as 1 treatment of morning Docetaxel and afternoon Low Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART). The first day of the first treatment is designated "study day 1".
Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy
A single fraction of LDFWART will be given 6-8 hours after the start of morning administration of Docetaxel for 6 cycles (the time of the start Docetaxel will be counted as the frame of reference for when the LDFWART can be given).
Other Name: LDFWART
Drug: Docetaxel
Chemotherapy will consist of 6 cycles of Docetaxel. Each cycle will follow standard of care and will be scheduled every 3 weeks ± 3 days. Chemotherapy should be administered in the morning to allow 6-8 hours before Radiation Therapy. On Day 1 of each cycle, chemotherapy will consist of Docetaxel 60 mg/m² infused intravenously over 30-60 minutes (with premedication of dexamethasone 10 mg given IV 30-60 minutes prior to docetaxel administration).
Other Name: Taxotere

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083536

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Aaron H Wolfson, MD    305-243-4210    awolfson@med.miami.edu   
Sub-Investigator: Lorraine Portelance, MD         
Sub-Investigator: Matthew Pearson, MD         
Sub-Investigator: Diann Fernandez, ARNP         
Sub-Investigator: Ellen Hopkins, ARNP         
Sub-Investigator: Brian Slomovitz, MD         
Sub-Investigator: Marilyn Huang, MD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Aaron H Wolfson, MD University of Miami
  More Information

Responsible Party: Aaron Wolfson, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02083536     History of Changes
Other Study ID Numbers: 20110671 
Study First Received: March 6, 2014
Last Updated: February 1, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Low Dose Fractionated Whole Abdominal Radiation Therapy
LDFWART
Docetaxel
Ovarian Cancer
Ovarian Carcinoma
Platinum-Resistant

Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016