Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study voluntarily stopped by Principal Investigator due to lack of accrual.
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Low Dose Fractionated Whole Abdominal Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDFWART + Docetaxel
- 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".
- interventionNames
- Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy
- Drug: Docetaxel
Primary outcomes (2)
- measure
- Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 3 years
- description
- Number of subjects experiencing adverse events after receiving protocol therapy.
- measure
- Recommended Phase II Dose of LDFWART
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available