Propranolol Hydrochloride and Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal,… (NCT01504126) | Clinical Trial Compass
CompletedEarly Phase 1
Propranolol Hydrochloride and Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
United States32 participantsStarted 2012-03-09
Plain-language summary
This early phase I trial studies giving propranolol hydrochloride with standard chemotherapy in treating patients with ovarian, primary peritoneal, or fallopian tube cancer. Biological therapies, such as propranolol hydrochloride, blocks certain chemicals that affect the heart and this may stimulate the immune system and allow the chemotherapy to kill more tumor cells.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma
* Stages II-IV of the above cancer
* Patients to be scheduled for a planned tumor debulking
* Intention for chemotherapy administration at MD Anderson Cancer Center
* Zubrod performance status 0-2
* Absolute neutrophil count (ANC) \>= 1500/ml
* Platelets \> 100,000/mL
* Creatinine clearance (CrCl) \> 50 mL/min
* Bilirubin =\< 1.5 x institutional upper limit normal
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 x institutional upper limit normal
* Alkaline phosphatase =\< 2.5 x institutional upper limit normal
* Neuropathy (sensory and motor) =\< grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE)
* Prothrombin time (PT) such that international normalized ratio (INR) is =\< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for the management of venous thrombosis…
What they're measuring
1
Proportion of patients who successfully complete 6 cycles of chemotherapy with propranolol hydrochloride