Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Cystadenocarcinoma, Serous

Endometrial Neoplasms

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma of the Appendix

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Paclitaxel

Dexamethasone

Albumin-Bound Paclitaxel

Dexamethasone acetate

Diphenhydramine

Promethazine

Cimetidine

Tubulin Modulators

Antimitotic Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Antacids

Anti-Ulcer Agents

Histamine H2 Antagonists

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.

Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.

50 mg/m\^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m\^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.

Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.

Pelvic Radiation

20 mg IV given 30 minutes prior to chemotherapy

300 mg IV given 30 minutes prior to chemotherapy

50 mg IV given 30 minutes prior to chemotherapy

Anuja Jhingran, MD

Primary Objectives:

* To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival.
* To evaluate the toxicity of Paclitaxel and pelvic radiation.
* To collect and evaluate patients' quality of life/symptom assessment data.

Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.

If you are found to be eligible to take part in this study, you will begin treatment. You will have radiation treatment to your pelvis (hip area) every day (Monday - Friday) for a total of 25 treatments. Each treatment should take about 20 minutes to complete.

After the radiation treatment, you will receive a type of radiation called a "vaginal cuff boost." The vaginal cuff boost involves a small device being inserted into the vagina to treat the back of the vagina with a high dose of radiation. The applicator is similar to placing a large tampon in the vagina. This internal treatment takes about 30 minutes for each treatment. This is separate from the external radiation treatments that are given.

While you are receiving radiation treatment, and then afterwards, you will also receive chemotherapy with paclitaxel. During the radiation period, you will receive paclitaxel by vein over 1 hour, on Days 1, 8, 15, 22, and 29. Starting 4-6 weeks after radiation treatment is finished, you will receive paclitaxel at a larger dose, given over 3 hours each time, once every 21 days (3 weeks). You will receive up to 4 "cycles" of chemotherapy, each cycle lasting 21 days.

You will be given certain drugs about 30 minutes before your chemotherapy treatments to help control possible side effects, like allergic reactions. These drugs include dexamethasone, diphenhydramine (Benadryl), and cimetidine.

You will have several tests performed throughout the study. Before each cycle of chemotherapy and one month after the last cycle of chemotherapy is given, quality of life and symptom assessment forms will be completed. These questionnaires should only take about 15 minutes to complete.

While you are on chemotherapy treatment, you will have tests performed before each chemotherapy treatment. This will involve blood (about 1 tablespoon) drawn for routine tests, and a review of your symptoms by the study staff.

Once you are off study treatment, you will be asked to return to the clinic for follow-up visits. These visits will occur every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year after that. At these visits, you will have a physical and pelvic exam performed, along with blood (about 1 tablespoon) drawn for routine tests. Chest x-rays will usually be done once a year and any other diagnostic exams will only be done if your doctor thinks they are needed.

This is an investigational study. There are no standard treatments for this type of endometrial cancer, but radiation and chemotherapy are common treatments. This combination of chemotherapy and radiation is considered experimental. Up to 49 patients will take part in this multicenter study. Up to 44 participants will be enrolled at M. D. Anderson.

Papillary Serous Carcinoma of the Endometrium

A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium

The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.

M.D. Anderson Cancer Center

Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.

Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.

Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy.

Paclitaxel (Taxol) + Pelvic Radiation

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Anuja Jhingran, MD / Professor, Radiation Oncology Department

2 Years

5 Years

Overall Survival at 2 Years and 5 Years

Overall Study

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Melanoma

Carcinoma, Renal Cell

Neoplasm Metastasis

Kidney Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Analgesics

Aldesleukin

Interferons

Interleukin-2

Interferon-alpha

Interferon-alfa-1b

Antiviral Agents

Immunologic Factors

Anti-HIV Agents

Anti-Retroviral Agents

aldesleukin

recombinant interferon alfa

therapeutic tumor infiltrating lymphocytes

cimetidine

Robert O. Dillman, MD, FACP

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.

OBJECTIVES: I. Determine the response rate and failure-free survival in patients with metastatic cancer (preferably melanoma or renal cell) treated with autologous tumor infiltrating lymphocytes (TIL), interferon alfa (IFN-A), and interleukin-2 (IL-2). II. Describe the toxic effects and costs associated with this therapy to assess risk benefit and cost benefit. III. Assess the relative value of administering low- or high-dose TIL, as well as the value of administering IFN-A before TIL, IL-2 with TIL, or cimetidine with TIL.

OUTLINE: This is a multicenter study. Patients are stratified according to center, tumor infiltrating lymphocyte (TIL) dose (low vs high), and medical condition suitable for interferon alfa (IFN-A)/interleukin-2 (IL-2) (yes vs no). Patients are assigned to one of two treatment regimens based on entry criteria. Regimen A (preferred): Patients meeting the preferred entry criteria receive IFN-A subcutaneously on days 1-4, TIL expanded in vitro with IL-2 IV on day 5, and IL-2 IV continuously over 72 hours following TIL infusion. Regimen B: All other patients receive TIL infusion once followed by oral cimetidine every 6 hours for 4 weeks. Treatment repeats in both regimens every 3-6 weeks in the absence of disease progression and according to TIL availability. Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 20-30 patients with melanoma and 20-30 patients with renal cell carcinoma will be accrued for this study.

Biological Therapy in Treating Patients With Metastatic Cancer

ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER

Hoag Memorial Hospital Presbyterian

Robert O. Dillman, MD

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma in Situ

Breast Diseases

Tin Fluorides

BB 1101

Famotidine

Ichthammol

Ranitidine

Ranitidine bismuth citrate

HIV Protease Inhibitors

Protease Inhibitors

Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.

Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.

Quality-of-Life Assessment

The Ohio State University Comprehensive Cancer Center

Michael J. Berger, Pharm.D.

Michael J Berger, Pharm.D.

This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer drugs which require parenteral rescue medication after stopping standard pre-medications (dexamethasone, diphenhydramine, famotidine/cimetidine/ranitidine), compared to continuing premedications. Paclitaxel is a drug used to treat breast cancer, ovarian cancer, and autoimmune deficiency syndrome (AIDS)-related Kaposi sarcoma. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. However, there are side-effects and toxicities associated with repeat exposure to this pre-medication regimen. With prolonged use of paclitaxel, especially during weekly regimens, patients are exposed to repeat doses of drugs that prevent hypersensitivity reactions. Side effects include, but are not limited to, insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. The information gained from this study may positively influence clinical practice and help researchers develop methods to safely stop pre-medications.

PRIMARY OBJECTIVE:

I. To estimate the difference in rates of infusion hypersensitivity reaction (HSR) requiring parenteral rescue medications following the discontinuation of pre-medications after 2 doses of paclitaxel, compared to continuing premedications, in breast cancer patients who have not experienced an infusion HSR with their first 2 paclitaxel doses.

OUTLINE:

Patients receive paclitaxel per standard of care as a single agent or in combination with dexamethasone intravenously (IV) and/or orally (PO), diphenhydramine IV and/or PO and either famotidine IV and/or PO, ranitidine IV and/or PO or cimetidine IV and/or PO. Patients who don't experience any infusion hypersensitivity reaction after the first 2 doses of paclitaxel are randomized to 1 of 2 arms.

ARM I (STANDARD OF CARE): Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.

ARM II (EXPERIMENTAL): Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.

Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel

Safely Stopping Pre-Medications in Patients Receiving Paclitaxel: A Randomized Trial

Each symptom will be summarized by median (range) at each time point by treatment arm and the weekly average will be compared between arms using the Wilcoxon rank sum test.

The frequency and percentages of patients who, after discontinuing pre-medications, request that the pre-medications be resumed to ameliorate side-effects that the patient thinks have worsened since pre-medications were stopped (i.e. nausea, rash, arthralgia) will be summarized.

Weight changes over time will be summarized at each time point using mean (standard deviation) and plotted by treatment arm. Weight change from baseline to 10 weeks post-randomization will be compared between arms that receive weekly paclitaxel using a t-test of two independent samples.

Will report the impact of patient self-reported allergies, prior to starting paclitaxel (2 or more versus 3 or less), on the incidence of infusion HSR and rescue medication usage. Frequency of patient self-reported allergies (2 or more versus less) on the incidence of infusion HSR and rescue medication usage will be tabulated.

The rates of rescue medication by arms will be estimated by race/ethnicity group to explore whether there is a differential effect from stopping hypersensitivity reaction by race/ethnicity.

Reaction rate will be summarized by paclitaxel manufacturer and lot number.

The proportion of patients having infusion HSR of grade 2 or greater requiring parental treatment (rescue medications) will be estimated along with a 95% confidence interval. The difference in proportions of patients with grade 2 or greater infusion HSR needing rescue medication will be estimated along with a 95% confidence interval using the Z-test of normal approximations of the binomial distributions. As a sensitivity analysis, will repeat the analysis including patients assigned to the discontinuation arm but decided to restart pre-medications and patients assigned to the continuation arm but demanded to have premedications discontinued as having experienced HSR.

Will determine whether an abbreviated pre-medication regimen results in improvement in patient-reported quality of life, as measured by an 11-point numerical analog scale. Patient-reported quality of life, based on a single item 11-point numerical analog scale at each time point as well as change from baseline will be summarized by median (range) separately by treatment arm. Median (mean) QoL scores will be plotted longitudinally by treatment arm. QoL change from baseline will be compared between arms using the Wilcoxon rank-sum test. Data will be captured every day, for one week after each dose of chemotherapy.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Papillary Serous Carcinoma of the Endometrium	NCT00515073	Endometrial Can...	Paclitaxel Pelvic Radiatio... Dexamethasone Cimetidine Diphenhydramine	-	M.D. Anderson Cancer Center
Biological Therapy in Treating Patients With Metastatic Cancer	NCT00002733	Kidney Cancer Melanoma (Skin) Unspecified Adu...	aldesleukin recombinant int... therapeutic tum... cimetidine	18 Years -	Hoag Memorial Hospital Presbyterian
Biological Therapy in Treating Patients With Metastatic Cancer	NCT00002733	Kidney Cancer Melanoma (Skin) Unspecified Adu...	aldesleukin recombinant int... therapeutic tum... cimetidine	18 Years -	Hoag Memorial Hospital Presbyterian
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel	NCT04862585	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Breast Carcinom... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag...	Cimetidine Dexamethasone Diphenhydramine Famotidine Paclitaxel Quality-of-Life... Ranitidine	18 Years -	Ohio State University Comprehensive Cancer Center
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel	NCT04862585	Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Anatomic Stage ... Breast Carcinom... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag... Prognostic Stag...	Cimetidine Dexamethasone Diphenhydramine Famotidine Paclitaxel Quality-of-Life... Ranitidine	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for cimetidine

Every month we try and update this database with for cimetidine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cimetidine

Every month we try and update this database with for cimetidine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cimetidine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.