Clinical Trials Directory

Trials / Completed

CompletedNCT01504126

Propranolol Hydrochloride and Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
32 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of pharmacologic beta-adrenergic blockade in women with stages II-IV epithelial ovarian cancer patients (n=25) either during initial tumor reductive surgery and through the first six cycles of standard intravenous chemotherapy or during neoadjuvant chemotherapy followed by surgery and further chemotherapy (chemo) up to a total of 6 cycles. SECONDARY OBJECTIVES: I. To characterize the biobehavioral states of these patients by using the Functional Assessment of Chronic Illness and Therapy- Ovary (FACT-O), Hospital Anxiety and Depression Survey (HADS) and the Center for Epidemiologic Studies Depression Scale (CESD) and serum levels of angiogenic cytokines at points pre- and post-treatment with beta-blockers. II. To follow patients for progression-free survival (PFS) and overall survival (OS). TRANSLATIONAL OBJECTIVES: I. Determining vascular endothelial growth factor (VEGF), interleukin (IL)-6, IL-8, and other cytokines levels in patients with ovarian cancer who are receiving beta-blockers and comparing these levels pre-treatment and during treatment with response. OUTLINE: Patients receive propranolol hydrochloride orally (PO) twice daily (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. After completion of study treatment, patients are followed up every 3 months for 1 year.

Conditions

Interventions

TypeNameDescription
DRUGChemotherapyUndergo standard chemotherapy
DRUGPropranolol HydrochlorideGiven PO
OTHERQuality-of-Life AssessmentAncillary studies
PROCEDURETherapeutic Conventional SurgeryUndergo surgical resection

Timeline

Start date
2012-03-09
Primary completion
2019-08-15
Completion
2019-08-15
First posted
2012-01-05
Last updated
2019-08-29

Locations

7 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01504126. Inclusion in this directory is not an endorsement.