Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients

NCT01308944 | Completed Phase 1 DMC

• 1 other identifier: 10-0447 / 201104047
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This research is looking at the effect of biobehavioral factors such as stress and whether these factors alter how the body responds to chemotherapy, one of the purposes of this study is to determine if the addition of a beta-blocker such as Propranolol (Inderal) is tolerable when given with chemotherapy in the treatment of newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer. An additional purpose of the study is to understand if behavioral factors such as depression and anxiety can alter different blood markers that affect tumor vascularity. The Investigator wishes to determine whether the use of beta-blocker drugs such as Inderal, might alter these behavioral factors by drawing blood prior to and after the administration of Inderal as well as giving behavioral questionaires at different time points. Beta-blockers are commonly used for the treatment of hypertension, protection of the heart after a heart attack, and irregularities in heartbeats. Altering these factors might boost the immune system and affect other areas of cancer biology, thereby allowing the chemotherapy to be more effective. The significance of this research is that it may help improve our treatments of this disease in the future.

Conditions

Invasive Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer

Keywords

invasive epithelial ovarian cancer,; primary peritoneal carcinoma,; fallopian tube cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of concurrent beta-blocker administration with chemotherapy

  Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol

  Completion of 6 cycles of chemotherapy/propranolol

Secondary Outcomes (4)

• Progression free survival rates

  From time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery

• Pilot data on blood markers in patients with ovarian cancer pre- and post-beta blockade

  Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo

• Characterization of biobehavioral states with surveys

  Pre-surgery, Completion of 3rd cycle of chemo, Completion of 2nd cycle of chemo

• Evaluation of immunohistochemistry of angiogenic markers on tumor samples

  At time of initial surgery

Study Arms (1)

Arm 1

EXPERIMENTAL

Propranolol 40mg po orally twice daily to begin at least 48 hours prior to surgical debulking. This will ideally be titrated in order to maintain a heart rate between 60 and 80 without hypotension. After surgery, the patient will resume the propranolol once tolerating clear liquids in the hospital and will remain on them until completion of chemotherapy. After completion of chemotherapy, the patient will be weaned off the medication over the following two weeks.

Drug: Propranolol

Interventions

Propranolol DRUG

Also known as: Inderal

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected preoperative diagnosis of invasive ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and CA-125 levels
• Patients must scheduled for a planned tumor debulking at least 72 hours in advance in order for the patient to take at least 48 hours of prescribed Propranolol
• Intention for chemotherapy administration at Washington University
• An approved informed consent and authorization permitting release of personal health information must be signed by patient or guardian
• Age ≥ 18 years
• Gynecologic Oncology Group performance status 0-2
• Patient's of childbearing age must have a negative pregnancy test

You may not qualify if:

• Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer are excluded.
• Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease
• Patients with a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions.
• With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present with the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded.
• Use of systemic glucocorticoids such as Prednisone or Decadron in the last month
• Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English
• Cirrhosis of the liver
• Patients with a GOG Performance status 3 or 4
• Patients under the age of 18
• Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis
• Any patients already on beta-blockers or contraindicated to receive beta-blockers
• Post-operative Eligibility Criteria:
• Histologic diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer. 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. However, the histologic features must be compatible with primary Müllerian epithelial adenocarcinoma. Patients with low grade invasive epithelial ovarian cancers may participate.
• Stages I-IV of the above cancer

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Premal Thaker, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: March 4, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)