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

August 9, 2016 updated by: Aaron Wolfson, University of Miami

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
Time Frame: 3 years
Number of subjects experiencing adverse events after receiving protocol therapy.
3 years
Recommended Phase II Dose of LDFWART
Time Frame: 3 years
The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy
Time Frame: Up to 5 years
Number of subjects experiencing complete response (CR) or partial response (PR) according to RECIST Criteria Version 1.1
Up to 5 years
The rate of Overall Survival in subjects receiving protocol therapy
Time Frame: Up to 5 years
Observed length of life from start of treatment to cause of death
Up to 5 years
The rate of Progression-Free Survival in subjects receiving protocol therapy.
Time Frame: Up to 5 years
Length of time from start of treatment to the time of documented disease progression in study subjects
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Aaron H Wolfson, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110671

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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