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

NCT02083536 | Withdrawn Phase 1 DMC

• 1 other identifier: 20110671
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Number of Subjects Experiencing Complete or Partial Response to Protocol Therapy

  Up to 5 years

• The rate of Overall Survival in subjects receiving protocol therapy

  Up to 5 years

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

  Up to 5 years

Study Arms (1)

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".

Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy; Drug: Docetaxel

Interventions

Low Dose Fractionated Whole Abdominal Radiation Therapy RADIATION

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).

Also known as: LDFWART

LDFWART + Docetaxel

Docetaxel DRUG

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).

Also known as: Taxotere

LDFWART + Docetaxel

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• 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 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.

You may not qualify if:

• \. 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).
• \. 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.

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Aaron H Wolfson, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 11, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2019
• Last Updated: August 10, 2016

Record last verified: 2016-08