Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Adenocarcinoma

Recurrence

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

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

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Lactams

Epothilones

Epothilone B

Tubulin Modulators

Antimitotic Agents

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ixabepilone

Don Dizon

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

PRIMARY OBJECTIVES:

I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Gynecologic Oncology Group

National Cancer Institute (NCI)

Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment

Ixabepilone

Age, Continuous

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent

Adenocarcinoma, Unspecified

Clear Cell Carcinoma

Endometrioid Adenocarcinoma

Mixed Epithelial Carcinoma

Serous Adenocarcinoma

Carcinosarcoma-homologous

Histologic Type

Angela M. Kuras, Associate Director of Data Management

Tumor Response

Leukopenia

Neutropenia

Anemia

Thrombocytopenia

Allergy/Immunology

Auditory/ear

Cardiac

Coagulation

Constitutional

Dermatologic

Gastrointestinal

Genitourinary

Hemorrhage

Infection

Lymphatics

Metabolic

Musculoskeletal

Neurosensory

Other neurologic

Ocular/visual

Pain

Pulmonary

Alopecia

Vascular

Number of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).

Grade 1

Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).

Grade 2

Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).

Grade 3

Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).

Grade 4

Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).

Grade 5

Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)

Progression-free Survival

Overall Survival

Overall Study

Spots Global Cancer Trial Database for Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial