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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00056 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2011-0800 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Sprint for Life | UNKNOWN |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (propranolol hydrochloride) | Experimental | Patients 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Undergo standard chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life as measured by the Functional Assessment of Chronic Illness and Therapy- Ovary (FACT-O) | Descriptive statistics will be used to summarize measurements at each assessment time, and boxplots and histograms will be used to illustrate the distribution of this outcome at each assessment time. Changes from baseline will be similarly summarized. If these data are approximately normally distributed, or transformable to be approximately normally distributed, mixed repeated measures models and linear contrasts will be used to test for changes over time and associations between these quantities. Highly skewed measures analyzed using nonparametric methods. |
| Measure | Description | Time Frame |
|---|---|---|
| "Changes in immune response, measured by serum levels of IL-6 | Descriptive statistics will be used to summarize measurements at each assessment time, and boxplots and histograms will be used to illustrate the distribution of this outcome at each assessment time. Changes from baseline will be similarly summarized. If these data are approximately normally distributed, or transformable to be approximately normally distributed, mixed repeated measures models and linear contrasts will be used to test for changes over time and associations between these quantities. Highly skewed measures analyzed using nonparametric methods. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lois M Ramondetta | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Lyndon Baines Johnson General Hospital |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Propranolol Hydrochloride | Drug | Given PO |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Therapeutic Conventional Surgery | Procedure | Undergo surgical resection |
|
| Baseline to up to 6 months |
| Changes in mood state as measured by the Hospital Anxiety and Depression Survey (HADS) | Descriptive statistics will be used to summarize measurements at each assessment time, and boxplots and histograms will be used to illustrate the distribution of this outcome at each assessment time. Changes from baseline will be similarly summarized. If these data are approximately normally distributed, or transformable to be approximately normally distributed, mixed repeated measures models and linear contrasts will be used to test for changes over time and associations between these quantities. Highly skewed measures analyzed using nonparametric methods. | Baseline to up to 6 months |
| Progression-free survival (PFS) | PFS will be estimated with the product-limit estimator of Kaplan and Meier illustrated with a Kaplan-Meier plot. Proportional hazards models will be used to examine the association between cytokines and PFS. | Up to 1 year |
| Overall survival (OS) | Will be estimated with the product-limit estimator of Kaplan and Meier. Proportional hazards models will be used to examine the association between cytokines and OS. | Up to 1 year |
| Incidence of adverse events | Adverse events will be tabulated with particular attention to grade 3-4 neutropenia and grade 2+ neurotoxicity. The incidence of each type of adverse event will be estimated with a 95% confidence interval. | Up to 1 year after completion of study treatment |
| Changes in mood state as measured by Center for Epidemiologic Studies Depression Scale (CES-D | scriptive statistics will be used to summarize measurements at each assessment time, and boxplots and histograms will be used to illustrate the distribution of this outcome at each assessment time. Changes from baseline will be similarly summarized. If these data are approximately normally distributed, or transformable to be approximately normally distributed, mixed repeated measures models and linear contrasts will be used to test for changes over time and associations between these quantities. Highly skewed measures analyzed using nonparametric methods. | Baseline to up to 6 months |
| Baseline to up to 6 months |
| Changes in immune response, measured by serum levels of IL-8 | Descriptive statistics will be used to summarize measurements at each assessment time, and box-plots and histograms will be used to illustrate the distribution of this outcome at each assessment time. Changes from baseline will be similarly summarized. If these data are approximately normally distributed, or transformable to be approximately normally distributed, mixed repeated measures models and linear contrasts will be used to test for changes over time and associations between these quantities. Highly skewed measures analyzed using non-parametric methods. | Baseline to up to 6 months |
| Changes in immune response, measured by serum levels of VEGF | Descriptive statistics will be used to summarize measurements at each assessment time, and boxplots and histograms will be used to illustrate the distribution of this outcome at each assessment time. Changes from baseline will be similarly summarized. If these data are approximately normally distributed, or transformable to be approximately normally distributed, mixed repeated measures models and linear contrasts will be used to test for changes over time and associations between these quantities. Highly skewed measures analyzed using non-parametric methods. | Baseline to up to 6 months |
| 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 |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011433 | Propranolol |
| C477592 | propranolol CR |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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