Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Adenocarcinoma

Uterine Cervical Neoplasms

Carcinoma, Adenosquamous

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Epothilones

Epothilone B

Tubulin Modulators

Antimitotic Agents

Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.

Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.

All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.

Participants received Ixabepilone 6mg/m\^2 for a total of 30mg/m\^2 inpatient or outpatient intravenously over an hour on the first five days of each 21 day cycle.

Ixempra (Ixabepilone (BMS-247550) )

Antonio T Fojo, M.D.

Background:

* Ixabepilone is a member of the class of drugs called epothilones. These drugs interfere with the ability of cancer cells to replicate.
* Epothilones are similar to taxanes, another class of drugs, which includes the drug Taxol. Taxol is widely used to treat a variety of cancers.
* Ixabepilone can work in cells that are resistant to Taxol.

Objectives:

* To determine whether ixabepilone is effective for treating cervical cancer.

Eligibility:

* Women 18 years of age or older with cervical cancer.

Design:

* Patients receive ixabepilone intravenously (through a vein) over 60 minutes on the first 5 days of each 21-day treatment cycle. Their dosage may be adjusted according to how their bodies respond to the drug.
* The number of cycles each woman receives depends on her response to the treatment.
* Patients have CT (computed tomography) scans and other tests before starting treatment and then every other treatment cycle to determine the response of the tumor to ixabepilone.
* Patients who can undergo a tumor biopsy (surgical removal of a sample of tumor tissue) are asked to have a biopsy done before starting treatment with ixabepilone and again on the fourth or fifth day of treatment. This procedure is optional.

Background

* Ixabepilone (Ixempra (Trademark), BMS-247550, NSC 710428) is a semi-synthetic analog of the natural product epothilone B.
* The epothilones are a novel class of non-taxane microtubule-stabilizing agents obtained from the fermentation of the cellulose degrading myxobacteria, Sorangium cellulosum.
* Ixabepilone is active against cancer models that are naturally insensitive to paclitaxel or have developed resistance to paclitaxel, both in-vitro and in-vivo.

Objectives

Primary-

- Establish the efficacy of the investigational agent ixabepilone in patients with cervical carcinoma when administered as a daily one-hour infusion on days 1 to 5 every three weeks, as measured by overall response (PR (partial response) +CR (complete response)).

Secondary-

* Assess pharmacodynamic endpoints to determine the extent of tubulin polymerization and whether or not there has been activation of cellular death pathways distal to the target.
* Estimate progression-free survival and duration of response.

Eligibility

* Age greater than 18
* Histologic or cytologic confirmation of cervical carcinoma; either squamous cell or non-squamous consisting of cervical adenocarcinoma, cervical adenosquamous carcinoma or cervical carcinoma, non-squamous type.

Design

* Phase II study, open, non-randomized
* Ixabepilone will be administered at a dose of 6mg/m\^2 daily on days 1 through 5, every three weeks.
* Restaging will be done every two cycles using RECIST (Response Evaluation Criteria in Solid Tumors)
* Planned maximum enrollment 76 persons

Ixabepilone to Treat Cervical Cancer

A Phase II Clinical Trial of Ixabepilone (Ixempra [R], BMS-247550, NSC 710428), an Epothilone B Analog, in Cervical Cancer

Establish the efficacy of the investigational agent Ixabepilone in patients with cervical carcinoma per the Response Evaluation Criteria in Solid Tumors (RECIST) when Ixabepilone is administered as a daily 1 hour infusion on days 1-5 every 3 weeks. Complete response (CR) is the disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Not evaluable (NE) means the participant was not evaluable because there was not a scan available to compare to the baseline scan.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

National Cancer Institute (NCI)

Principal Investigator

Adverse Events for Squamous and Non-squamous Participants

Squamous and Nonsquamous Participants

Age, Continuous

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Antonio Fojo, M.D.

Not Evaluable (only 1 cycle)

Progressive Disease

Stable Disease

Partial Response

Complete Response

Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.

Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m\^2 x 5 days, each cycle.

Number of Participants With a Tumor Response (PR + CR) Per RECIST

Adverse events are grouped together because the histology cohort has no bearing on the adverse events.

Number of Participants With Serious and Non-Serious Adverse Events

Overall Study

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Fallopian Tube Diseases

Ovarian Cancer

epothilone b

Novartis Pharmaceuticals

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

duration of response in patients with complete response (CR) or partial response (PR)

Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations

Skin and Connective Tissue Diseases

Melanoma

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

Neuroendocrine Tumor

Neuroepithelioma

intravenous 2.5 mg/m2 as a 5 minutes bolus infusion once every week for three weeks followed by one week off

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.

EPO906 Therapy in Patients With Advanced Melanoma

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Melanoma

Objective tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines assessed by radiologic techniques and/or physical examination.

Safety and tolerabilty of EPO906: Safety assessments consisted of monitoring and recording of all adverse events (AEs) and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs and the performance status.

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Androgens

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.

EPO906 Therapy in Patients With Prostate Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

Colorectal Neoplasms

Colonic Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

Cola

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause colorectal cancer.

EPO906 Therapy in Patients With Advanced Colorectal Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Colorectal Cancer

External Affairs

Breast Neoplasms

Breast Diseases

Taxane

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.

EPO906 Therapy in Patients With Advanced Breast Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer

Carcinoid Tumor

Gastrinoma

Vipoma

Zollinger-Ellison Syndrome

VIPoma

EPO906 epothilone B

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.

EPO906 in Carcinoid and Other Neuroendocrine Tumors

EPO906 Therapy in Patients With Metastatic Carcinoid Tumors and Other Neuroendocrine Tumors

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

EPO906 administered intravenously at 2.5 mg/m2 as a 5 minute bolus infusion repeated every week for three weeks followed by one week off The final tables and data is not in yet, so I cannot give you info on safety issues.

This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

EPO906 Therapy in Patients With Advanced Kidney Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Sagopilone

Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion

Sagopilone (BAY86-5302, ZK 219477)

Bayer Study Director

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ixabepilone to Treat Cervical Cancer	NCT00924066	Cervical Carcin... Cervical Adenoc... Cervical Adenos... Cervical Carcin...	Ixempra (Ixabep...	18 Years - 80 Years	National Institutes of Health Clinical Center (CC)
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer	NCT00035100	Ovarian Neoplas... Peritoneal Neop... Fallopian Tube ...	epothilone b	18 Years -	Novartis
EPO906 Therapy in Patients With Advanced Melanoma	NCT00035165	Melanoma	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Prostate Cancer	NCT00035113	Prostatic Neopl...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Colorectal Cancer	NCT00035087	Colorectal Neop... Colonic Neoplas...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Breast Cancer	NCT00035126	Breast Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
EPO906 in Carcinoid and Other Neuroendocrine Tumors	NCT00050349	Carcinoid Neuroendocrine ...	EPO906 epothilo...	18 Years -	Novartis
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Prostate Cancer	NCT00035113	Prostatic Neopl...	epothilone b	18 Years - 85 Years	Novartis
EPO906 in Carcinoid and Other Neuroendocrine Tumors	NCT00050349	Carcinoid Neuroendocrine ...	EPO906 epothilo...	18 Years -	Novartis
EPO906 Therapy in Patients With Advanced Breast Cancer	NCT00035126	Breast Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
EPO906 Therapy in Patients With Advanced Kidney Cancer	NCT00035243	Kidney Neoplasm...	epothilone b	18 Years - 85 Years	Novartis
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer	NCT00299390	Small Cell Lung...	Sagopilone (BAY...	18 Years -	Bayer
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer	NCT00299390	Small Cell Lung...	Sagopilone (BAY...	18 Years -	Bayer

Spots Global Cancer Trial Database for epothilone

Every month we try and update this database with for epothilone 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 epothilone

Every month we try and update this database with for epothilone 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 epothilone 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.