- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01308944
Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
Feasibility Study: Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Missouri
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St Louis, Missouri, United States, 63110
- Washington University in St. Louis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Preoperative Eligibility Criteria:
Inclusion Criteria
- 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
Exclusion Criteria
- 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:
Inclusion 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
- Patients having undergone a suboptimal or optimal tumor debulking
- Gynecologic Oncology Group performance status 0-2
Patients must have adequate:
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1500/ml.
- Platelets greater than 100,000/ml
- Renal function: Creatinine ≤ 1.5 x institutional upper limit normal
- Hepatic function: Bilirubin less than or equal to 1.5 x institutional upper limit normal; SGOT and alkaline phosphatase less than or equal to 2.5 x institutional upper limit normal.
- Neurologic function: Neuropathy (sensory and motor) less than or equal to grade 1 according to Common Toxicity Criteria for Adverse Events version 3 (CTCAE).
- Blood coagulation parameters: 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) and a PTT <1.2 times institutional upper limit of normal.
Exclusion Criteria
- 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. Patients cannot receive concurrent bevacizumab or other targeted therapy as part of their primary chemotherapy.
- 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 synchronous 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
- Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
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. |
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of concurrent beta-blocker administration with chemotherapy
Time Frame: Completion of 6 cycles of chemotherapy/propranolol
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Proportion of patients who successfully complete 6 cycles of chemotherapy and concurrent treatment with propranolol
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Completion of 6 cycles of chemotherapy/propranolol
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival rates
Time Frame: From time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery
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From time of diagnosis to 1 year following the 6th cycle of chemotherapy or 18 months following surgery
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Pilot data on blood markers in patients with ovarian cancer pre- and post-beta blockade
Time Frame: Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo
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Pre-surgery, Completion of 3rd cycle of chemo, Completion of 6th cycle of chemo
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Characterization of biobehavioral states with surveys
Time Frame: Pre-surgery, Completion of 3rd cycle of chemo, Completion of 2nd cycle of chemo
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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)
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Pre-surgery, Completion of 3rd cycle of chemo, Completion of 2nd cycle of chemo
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Evaluation of immunohistochemistry of angiogenic markers on tumor samples
Time Frame: At time of initial surgery
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Immunohistochemistry for VEGF, IL-6, IL-8, MMP-2 and MMP-9 will be performed on tumor samples.
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At time of initial surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Premal Thaker, MD, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
Other Study ID Numbers
- 10-0447 / 201104047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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