Trial record 1 of 1497 for:    "Ovarian Neoplasms"
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Low-Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART) With Carboplatin and Docetaxel in Patients With Recurrent Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 25, 2014
Last verified: July 2014
  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 Carboplatin and docetaxel for 6 cycles in patients with recurrent platinum-sensitive and - 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: Carboplatin
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 Carboplatin & Docetaxel Chemo-Potentiator for Patients With 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 LDFWART + Chemo study therapy. To determine the safety and recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of carboplatin and docetaxel chemotherapy for patients with recurrent carcinoma of the ovary (without extra-abdominal extent of disease).


Secondary Outcome Measures:
  • Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy [ Time Frame: 3 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: 3 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: 3 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 + Chemo
This study has 6 treatment cycles given at 3 weeks intervals ± 3 days. A cycle is defined as 1 treatment of morning chemotherapy and afternoon LDF-WART. 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 and Carboplatin 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: Carboplatin
Chemotherapy will consist of 6 cycles of Docetaxel and Carboplatin. 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) followed by Carboplatin AUC 5 IV over 30 - 60 minutes.
Drug: Docetaxel
Chemotherapy will consist of 6 cycles of Docetaxel and Carboplatin. 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) followed by Carboplatin AUC 5 IV over 30 - 60 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: University of Miami Sylvester Comprehensive Cancer Center    866-574-5124    sylvester@emergingmed.com   
Contact: Aaron H Wolfson, MD    305-243-4210    awolfson@med.miami.edu   
Sub-Investigator: Lorraine Portelance, MD         
Sub-Investigator: Matthew Pearson, MD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Aaron H Wolfson, MD University of Miami
  More Information

No publications provided

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: July 25, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014