Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

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Gastrointestinal Agents

Docetaxel

Dexamethasone

Dexamethasone acetate

Tubulin Modulators

Antimitotic Agents

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".

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).

Low Dose Fractionated Whole Abdominal Radiation Therapy

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).

Aaron H Wolfson, MD

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.

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

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

Number of subjects experiencing adverse events after receiving protocol therapy.

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

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

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

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

University of Miami

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma	NCT02083536	Ovarian Cancer Ovarian Carcino... Recurrent Ovari... Recurrent Ovari...	Low Dose Fracti... Docetaxel	18 Years - 80 Years	University of Miami
LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma	NCT02083536	Ovarian Cancer Ovarian Carcino... Recurrent Ovari... Recurrent Ovari...	Low Dose Fracti... Docetaxel	18 Years - 80 Years	University of Miami

Spots Global Cancer Trial Database for low dose fractionated whole abdominal radiation therapy