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

University of Miami

Status and phase: Withdrawn; Phase 1

Conditions: Recurrent Ovarian Cancer; Recurrent Ovarian Carcinoma; Ovarian Carcinoma; Ovarian Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02083536

20110671

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

LDFWART + Docetaxel

Experimental group

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".

Treatment:

Drug: Docetaxel

Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy