Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer

NCT00971945

Breast Cancer

COMPLETED PHASE2

Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Breast Cancer

NCT01023204

Breast Cancer

COMPLETED PHASE2

Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors

NCT01653470

Cancer

COMPLETED PHASE1

A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

NCT02051751

Neoplasms, Breast Neoplasms, Head and Neck Neoplasms

COMPLETED PHASE1

A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin

NCT00420186

Cancer (Solid Tumors)

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Paclitaxel

One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent.

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paclitaxel

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Taxol BMS-181339

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).

Eligible Sex

ALL

Accepts Healthy Volunteers

No