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| ID | Type | Description | Link |
|---|---|---|---|
| JT 7408 | Other Identifier | JeffTrial Number |
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The trial was halted prematurely due to slow accrual.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This randomized phase II trial studies the effects of acetylcysteine and topotecan hydrochloride on the tumor microenvironment, or cells that make up a tumor, compared to topotecan hydrochloride alone in patients with ovarian, fallopian tube, or primary peritoneal cancer that has not responded to treatment (persistent) or has returned after a period of improvement (recurrent) and is high grade (likely to grow and spread quickly). Research has shown that cancer cells may be able to convert nearby normal cells into cancer cells. Acetylcysteine may stop this from happening. Topotecan hydrochloride is a chemotherapy drug used to treat ovarian cancer, and may help acetylcysteine work better. This trial studies the effect of acetylcysteine and topotecan hydrochloride on the tumor microenvironment to see if they can help make it more difficult for tumor cells to grow.
PRIMARY OBJECTIVES:
I. To estimate the proportion of subjects with persistent or recurrent high grade endometrioid or serous ovarian carcinoma who demonstrate a downregulation of monocarboxylate transporter 4 (MCT4) in the ovarian stroma in response to exposure to topotecan (topotecan hydrochloride) and N-acetylcysteine (NAC) (acetylcysteine) as compared to topotecan alone.
SECONDARY OBJECTIVES:
I. To determine the expression levels of caveolin 1 (Cav-1), solute carrier family 16 (monocarboxylate transporter), member 1 (MCT1), translocase of outer mitochondrial membrane 20 homolog (yeast) (TOMM20), fatty acid binding protein 4, adipocyte (FABP4), hypoxia inducible factor 1, alpha subunit (HIF-1 alpha) and NF kappaB activating protein (NFκB) in pathological samples of tumors after therapy with NAC relative to samples taken at time of initial diagnosis.
II. To assess the potential impact of NAC on progression free survival, overall survival, objective tumor response- complete or partial, and duration of response.
III. To estimate the proportion of subjects who survive progression free for at least 6 months and the proportion of patients who have objective tumor response, complete or partial in response to therapy IV. To assess safety and tolerability of NAC plus topotecan treatment in subjects with endometrioid or serous ovarian carcinoma by Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 criteria.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine orally (PO) twice daily (BID) on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (topotecan hydrochloride) | Active Comparator | Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Arm II (topotecan hydrochloride, acetylcysteine) | Experimental | Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topotecan Hydrochloride | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Demonstrate a Downregulation of MCT4 | The two-sided Fisher's exact test with alpha 0.05 will be used to compare the proportions of subjects who demonstrate a downregulation of MCT4 between subjects treated with topotecan hydrochloride and NAC and topotecan hydrochloride alone. | Baseline to up to day 20 after first course of topotecan hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Expression Levels of Cav-1 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | Baseline to up to day 20 after first course of topotecan hydrochloride |
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Inclusion Criteria:
Patient must have persistent or recurrent high grade endometrioid or serous ovarian, primary peritoneal or fallopian tube carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
All patients must have measurable disease that is amenable to biopsy. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥20 mm when measured by conventional techniques including palpation, plain film x-ray, CT, and MRI, or ≥ 10 mm when measured by high resolution CT.
Patient must have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days following completion of radiation therapy.
Patients must have a GOG performance status of 0, 1, or 2.
Patients must be free of active infections requiring antibiotics, with the exception of uncomplicated urinary tract infections (UTIs).
Any hormonal therapy directed at the tumor must be discontinued at least one week prior to initiation of therapy. Continuation of hormone replacement therapies is permitted.
Any other prior therapy directed at the tumor, including immunologic agents, must be discontinued at least 3 weeks prior to initiation of therapy.
Patients must have had at least one prior platinum/taxane combination chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatin compound. This initial treatment may include intraperitoneal therapy, high dose therapy, consolidation, noncytotoxic agents, or extended therapy.
Patients must be platinum resistant- defined as progressive disease while receiving platinum therapy or within 6 months of completing first line platinum therapy or patients who have progressive disease after two lines of platinum based treatment.
Patients Must Have Adequate:
Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Patients must meet pre-entry requirements as specified.
In the unlikely event that patients are still of childbearing potential, these patients must have a negative serum pregnancy test within 72 hours prior to initiating protocol therapy and be practicing an effective form of contraception during protocol therapy and for at least 4 weeks following completion of protocol therapy.
Patients must be 18 years of age or older.
Patients must not be receiving any other investigational agent.
Patients must be able to swallow whole pills. -
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell Schilder, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Jefferson University Hospitals | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Topotecan Hydrochloride) | Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Topotecan Hydrochloride | Drug | Given IV |
|
|
| Acetylcysteine | Drug | Given IV and PO |
|
|
| Change in Expression Levels of MCT1 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | Baseline to up to day 20 after first course of topotecan hydrochloride |
| Change in Expression Levels of TOMM20 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | Baseline to up to day 20 after first course of topotecan hydrochloride |
| Change in Expression Levels of FABP4 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | Baseline to up to day 20 after first course of topotecan hydrochloride |
| Change in Expression Levels of HIF-1 Alpha in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | Baseline to up to day 20 after first course of topotecan hydrochloride |
| Change in Expression Levels of NFκB in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | Baseline to up to day 20 after first course of topotecan hydrochloride |
| Change in Number of Circulating Tumor Cells | Compared pre-therapy and post- 1 cycle of therapy with a Fisher's exact test. | Baseline to day 29 |
| Progression-free Survival | Compared between the two arms using the log-rank test. | Up to 24 months |
| Overall Survival | Compared between the two arms using the log-rank test. | Up to 24 months |
| Objective Tumor Response Rates | Evaluated using the exact binomial confidence intervals and compared between the two arms using the Fisher's exact test. | Up to 24 months |
| Duration of Response | Compared between the two arms using the two-sample Wilcoxon test. | Up to 24 months |
| Proportion of Patients Experiencing Adverse Events, Evaluated Using the National Cancer Institute CTCAE Version 4.0 | Tabulated and reported with the corresponding exact binomial confidence intervals. | Up to 24 months |
| Arm II (Topotecan Hydrochloride, Acetylcysteine) |
Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV Acetylcysteine: Given IV and PO |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Topotecan Hydrochloride) | Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV |
| BG001 | Arm II (Topotecan Hydrochloride, Acetylcysteine) | Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV Acetylcysteine: Given IV and PO |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Who Demonstrate a Downregulation of MCT4 | The two-sided Fisher's exact test with alpha 0.05 will be used to compare the proportions of subjects who demonstrate a downregulation of MCT4 between subjects treated with topotecan hydrochloride and NAC and topotecan hydrochloride alone. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
|
| ||||||||||||||||||||||
| Secondary | Change in Expression Levels of Cav-1 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
| |||||||||||||||||||||||
| Secondary | Change in Expression Levels of MCT1 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
| |||||||||||||||||||||||
| Secondary | Change in Expression Levels of TOMM20 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
| |||||||||||||||||||||||
| Secondary | Change in Expression Levels of FABP4 in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
| |||||||||||||||||||||||
| Secondary | Change in Expression Levels of HIF-1 Alpha in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
| |||||||||||||||||||||||
| Secondary | Change in Expression Levels of NFκB in Tissue Samples | Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to up to day 20 after first course of topotecan hydrochloride |
| |||||||||||||||||||||||
| Secondary | Change in Number of Circulating Tumor Cells | Compared pre-therapy and post- 1 cycle of therapy with a Fisher's exact test. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Baseline to day 29 |
|
| ||||||||||||||||||||||
| Secondary | Progression-free Survival | Compared between the two arms using the log-rank test. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Up to 24 months |
|
| ||||||||||||||||||||||
| Secondary | Overall Survival | Compared between the two arms using the log-rank test. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Up to 24 months |
|
| ||||||||||||||||||||||
| Secondary | Objective Tumor Response Rates | Evaluated using the exact binomial confidence intervals and compared between the two arms using the Fisher's exact test. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Up to 24 months |
|
| ||||||||||||||||||||||
| Secondary | Duration of Response | Compared between the two arms using the two-sample Wilcoxon test. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Up to 24 months |
|
| ||||||||||||||||||||||
| Secondary | Proportion of Patients Experiencing Adverse Events, Evaluated Using the National Cancer Institute CTCAE Version 4.0 | Tabulated and reported with the corresponding exact binomial confidence intervals. | The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed. | Posted | Up to 24 months |
|
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Topotecan Hydrochloride) | Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 (+/- 1 day window for each treatment day). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV | 0 | 0 | 0 | 0 | ||
| EG001 | Arm II (Topotecan Hydrochloride, Acetylcysteine) | Patients receive topotecan hydrochloride as in Arm I. Patients also receive acetylcysteine IV over 60 minutes on days 1, 8, 15, and 22 (+/- 1 day window for each treatment day) and acetylcysteine PO BID on days 2-7, 9-14, 16-21, and 23-28, unless administration window was utilized. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Topotecan Hydrochloride: Given IV Acetylcysteine: Given IV and PO | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Activated Partial Thromboplastin Time prolonged | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| ANC decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Creatine Increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dizziness | General disorders | Non-systematic Assessment |
| ||
| Dry mouth | General disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Elevated WBC urine | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Gastrointestinal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hypercalcemia | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypertension | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hypocalcemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| INR increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Insomnia | General disorders | Non-systematic Assessment |
| ||
| Lipase increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Lymphocyte Count Decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Musculoskeletal and Connective Tissue disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nausea | General disorders | Non-systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Neutrophil count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Non-cardiac Chest pain | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Platelet Count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Presyncope | General disorders | Non-systematic Assessment |
| ||
| Sinusitis | General disorders | Non-systematic Assessment |
| ||
| Skin Biopsy | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Tearing | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| UTI | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vaginal Spotting | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| White blood cell decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Right side chest pain | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Russell Schilder | Sidney Kimmel Cancer Center at Thomas Jefferson University | 215-503-3057 | russell.schilder@jefferson.edu |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian 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 |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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