Ovarian CancerPhase 1NCT02083536
LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
A Phase 1 study testing Low Dose Fractionated Whole Abdominal Radiation Therapy and Docetaxel in people with Ovarian Cancer and Ovarian Carcinoma, run by University of Miami.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Carcinoma, Recurrent Ovarian Cancer
- What is being tested?
- Low Dose Fractionated Whole Abdominal Radiation Therapy and Docetaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2014to May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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.
- Being tested
- Low Dose Fractionated Whole Abdominal Radiation Therapy, Docetaxel
- Keywords
- Low Dose Fractionated Whole Abdominal Radiation Therapy, LDFWART, Docetaxel, Ovarian Cancer, Ovarian Carcinoma, Platinum-Resistant
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Fractionated Whole Abdominal Radiation TherapyRadiation
Also called LDFWART
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).
DocetaxelDrug
Also called Taxotere
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).
| Study group | Role | What they receive |
|---|---|---|
| LDFWART + Docetaxel | Experimental | 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". Receives: Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
Number of subjects experiencing adverse events after receiving protocol therapy.
Measured: 3 years
Recommended Phase II Dose of LDFWART
The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.
Measured: 3 years
Secondary outcomes (3)
Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy
Number of subjects experiencing complete response (CR) or partial response (PR) according to RECIST Criteria Version 1.1
Measured: Up to 5 years
The rate of Overall Survival in subjects receiving protocol therapy
Observed length of life from start of treatment to cause of death
Measured: Up to 5 years
The rate of Progression-Free Survival in subjects receiving protocol therapy.
Length of time from start of treatment to the time of documented disease progression in study subjects
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2019 (estimated)
Why it stopped: Study voluntarily stopped by Principal Investigator due to lack of accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Wolfson, University of Miami
- Investigators
- Aaron H Wolfson, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083536
- Sponsor's protocol ID
- 20110671
- Status last verified
- Aug 2016
- First submitted
- 6 Mar 2014
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02083536
- Acronym / sponsor ID
- 20110671
- Keywords
- Low Dose Fractionated Whole Abdominal Radiation Therapy, LDFWART, Docetaxel, Ovarian Cancer, Ovarian Carcinoma, Platinum-Resistant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study voluntarily stopped by Principal Investigator due to lack of accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2019 (estimated)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDFWART + Docetaxel | Experimental | Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy, Drug: DocetaxelThis 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". |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Fractionated Whole Abdominal Radiation TherapyAlso: LDFWARTA 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). | Radiation | LDFWART + Docetaxel |
| DocetaxelAlso: TaxotereChemotherapy 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). | Drug | LDFWART + Docetaxel |
Primary outcome
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.
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 secondary outcomes
Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy
Time frame: Up to 5 years
The rate of Overall Survival in subjects receiving protocol therapy
Time frame: Up to 5 years
The rate of Progression-Free Survival in subjects receiving protocol therapy.
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron H Wolfson, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Dose Fractionated Whole Abdominal Radiation Therapy and Docetaxel in people with Ovarian Cancer and Ovarian Carcinoma, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.