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
3 other identifiers
interventional
32
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Mar 2012
Longer than P75 for early_phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2012
CompletedFirst Posted
Study publicly available on registry
January 5, 2012
CompletedStudy Start
First participant enrolled
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2019
CompletedAugust 29, 2019
August 1, 2019
7.4 years
January 3, 2012
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients who successfully complete 6 cycles of chemotherapy with propranolol hydrochloride
The success rate will be estimated with a 90% credible interval.
Up to 6 months
Secondary Outcomes (6)
Changes in quality of life as measured by the Functional Assessment of Chronic Illness and Therapy- Ovary (FACT-O)
Baseline to up to 6 months
Changes in mood state as measured by the Hospital Anxiety and Depression Survey (HADS)
Baseline to up to 6 months
Progression-free survival (PFS)
Up to 1 year
Overall survival (OS)
Up to 1 year
Incidence of adverse events
Up to 1 year after completion of study treatment
- +1 more secondary outcomes
Other Outcomes (3)
"Changes in immune response, measured by serum levels of IL-6
Baseline to up to 6 months
Changes in immune response, measured by serum levels of IL-8
Baseline to up to 6 months
Changes in immune response, measured by serum levels of VEGF
Baseline to up to 6 months
Study Arms (1)
Treatment (propranolol hydrochloride)
EXPERIMENTALPatients 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.
Interventions
Undergo standard chemotherapy
Given PO
Ancillary studies
Undergo surgical resection
Eligibility Criteria
You may qualify if:
- 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)
- +6 more criteria
You may not qualify if:
- Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); 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; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study
- 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 synchronous primary endometrial cancer, or 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 International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
- Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer
- 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
- Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
- 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 or Spanish
- Cirrhosis of the liver
- Patients with a Zubrod performance status 3 or 4
- Comorbid conditions: Addison's disease, autoimmune hepatitis, hepatitis B, hepatitis C, acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV), lupus erythematosus, mixed connective tissue disease, rheumatoid arthritis
- Any patients already on beta-blockers or contraindicated to receive beta-blockers
- Hypersensitivity to propranolol, or beta-blockers
- Uncompensated congestive heart failure
- Cardiogenic shock
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Sprint for Lifecollaborator
Study Sites (7)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Lyndon Baines Johnson General Hospital
Houston, Texas, 77026-1967, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
The Woman's Hospital of Texas
Houston, Texas, 77054, United States
MD Anderson in Katy
Houston, Texas, 77094, United States
MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
MD Anderson in The Woodlands
The Woodlands, Texas, 77384, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lois M Ramondetta
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2012
First Posted
January 5, 2012
Study Start
March 9, 2012
Primary Completion
August 15, 2019
Study Completion
August 15, 2019
Last Updated
August 29, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share