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

Primary Purpose

Ovarian Cancer, Ovarian Carcinoma, Recurrent Ovarian Cancer

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Low Dose Fractionated Whole Abdominal Radiation Therapy

Docetaxel

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Low Dose Fractionated Whole Abdominal Radiation Therapy, LDFWART, Docetaxel, Ovarian Cancer, Ovarian Carcinoma, Platinum-Resistant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LDFWART + Docetaxel

Arm Description

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".

Outcomes

Primary Outcome Measures

Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability

Number of subjects experiencing adverse events after receiving protocol therapy.

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.

Secondary Outcome Measures

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

The rate of Overall Survival in subjects receiving protocol therapy

Observed length of life from start of treatment to cause of death

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

Full Information

NCT ID

NCT02083536

First Posted

March 6, 2014

Last Updated

August 9, 2016

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT02083536

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Study voluntarily stopped by Principal Investigator due to lack of accrual.

Study Start Date

May 2014 (undefined)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDFWART + Docetaxel

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Low Dose Fractionated Whole Abdominal Radiation Therapy

Other Intervention Name(s)

LDFWART

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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).

Primary Outcome Measure Information:

Title

Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability

Description

Number of subjects experiencing adverse events after receiving protocol therapy.

Time Frame

3 years

Title

Recommended Phase II Dose of LDFWART

Description

The recommended phase II dose of low-dose whole abdominal radiation therapy (LDFWART) when used in conjunction with 6 cycles of docetaxel chemotherapy.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy

Description

Number of subjects experiencing complete response (CR) or partial response (PR) according to RECIST Criteria Version 1.1

Time Frame

Up to 5 years

Title

The rate of Overall Survival in subjects receiving protocol therapy

Description

Observed length of life from start of treatment to cause of death

Time Frame

Up to 5 years

Title

The rate of Progression-Free Survival in subjects receiving protocol therapy.

Description

Length of time from start of treatment to the time of documented disease progression in study subjects

Time Frame

Up to 5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aaron H Wolfson, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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