Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

Status: Completed
Location: See all (7) locations...
Intervention Type: Other, Drug, Procedure
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 including pulmonary embolus)

• Partial thromboplastin time (PTT) \< 1.2 times institutional upper limit of normal

• Pulse \>= 60 beat per minute (bpm)

• Systolic blood pressure (SBP) \> 110 mmHg; diastolic blood pressure (DBP) \>= 60 mmHg

• Normotensive individuals not already on beta blockers (may be on other anti hypertensives): SBP =\< 140, DBP =\< 90

• Surgery or neoadjuvant chemotherapy must be scheduled at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed propranolol and have stable vital signs confirmed

• An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian

• Patients of childbearing age must have a negative pregnancy test

• Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer

Locations
United States
Arizona
Banner MD Anderson Cancer Center
Gilbert
Texas
Lyndon Baines Johnson General Hospital
Houston
M D Anderson Cancer Center
Houston
MD Anderson in Katy
Houston
The Woman's Hospital of Texas
Houston
MD Anderson in Sugar Land
Sugar Land
MD Anderson in The Woodlands
The Woodlands
Time Frame
Start Date: 2012-03-09
Completion Date: 2019-08-15
Participants
Target number of participants: 32
Treatments
Experimental: Treatment (propranolol hydrochloride)
Patients receive propranolol hydrochloride PO BID beginning 48-72 hours before treatment. Patients undergoing surgery resume propranolol hydrochloride post-operatively once oral drugs are tolerated and continue until completion of 6 cycles of chemotherapy. Patients undergoing neoadjuvant chemotherapy continue propranolol hydrochloride PO BID during 3 chemotherapy cycles pre-surgery and 3 cycles post-surgery. Treatment repeats every 3 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Sprint for Life, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials