Status:
TERMINATED
Feasibility - Beta Adrenergic Blockade (BB) in Cervical Cancer (CX)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Cervical Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn how many patients with advanced, recurrent, incurable cervical cancer will complete questionnaires about symptoms, any anxiety, depression, and/or ...
Detailed Description
Study Therapy Administration: If you are found to be eligible to take part in this study, you will take propranolol by mouth 2 times a day. While taking the drug, you should continue to check your b...
Eligibility Criteria
Inclusion
- Proven recurrent cervical cancer of any histology not eligible for curative radiotherapy or surgery.
- Failed chemotherapy for first recurrence (excluding chemotherapy with concurrent irradiation) or refractory to first line systemic therapy.
- Measurable or non-measurable disease
- Unlimited prior therapies
Exclusion
- Patients whose disease may be cured by surgery or radiotherapy.
- Contraindication to use of a beta-blocker.(uncontrolled DM, COPD-unstable, Bradycardia \<50 BPM)
- Already receiving a beta-blocker.
- Performance status \>3. Must have had treatment for first line recurrence
- 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.
- 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 within 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 for greater than one week
- Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish.
- Cirrhosis of the liver
- Patients under the age of 18
- History of comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, AIDS or HIV, lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis.
- Hypersensitivity to propranolol, or beta-blockers
- Uncompensated congestive heart failure
- Cardiogenic shock
- Severe sinus bradycardia; heart block, second or third degree or sick sinus syndrome (if no artificial pacemaker present)
- Severe hyperactive airway disease (chronic obstructive pulmonary disease, asthma)
- Any patients on Avastin or any other anti-angiogenic drugs.
- Patients with brittle diabetes mellitus (DM). Brittle diabetes mellitus is a type of diabetes when a person's blood glucose (sugar) level often swings quickly from high to low and from low to high. Also called "unstable diabetes" or "labile diabetes."
- Patients participating in or who plan to participate in other treatment trials during the course of this study.
- Patients actively using cocaine
- Cannot be receiving any other active neoplastic treatment during 4 months of study.
Key Trial Info
Start Date :
September 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01902966
Start Date
September 11 2013
End Date
August 14 2020
Last Update
October 12 2021
Active Locations (2)
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1
Lyndon B. Johnson General Hospital (LBJ)
Houston, Texas, United States, 77030
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030