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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02083536
• Other study ID #: 20110671
• Status: Withdrawn
• Phase: Phase 1
• First received: March 6, 2014
• Last updated: August 9, 2016
• Start date: May 2014

Study information

• Verified date: August 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Carcinoma
• Ovarian Neoplasms
• Recurrent Ovarian Cancer
• Recurrent Ovarian Carcinoma

Intervention

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).

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability	Number of subjects experiencing adverse events after receiving protocol therapy.	3 years	Yes
Primary	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.	3 years	Yes
Secondary	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	Up to 5 years	No
Secondary	The rate of Overall Survival in subjects receiving protocol therapy	Observed length of life from start of treatment to cause of death	Up to 5 years	No
Secondary	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	Up to 5 years	No