Study of Xyotax (CT-2103) in Patients With Metastatic Bre... | NCT00148707

Studies
Study of Xyotax (CT-2103) in Patients With Metastatic Breast Cancer

NCT00148707

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Dec 21, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Breast Cancer
Metastatic Breast Cancer

Interventions

CT-2103 (Xyotax)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2004

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2007

Last Update Posted Date

Dec 21, 2007Estimated

Name	Class
Beth Israel Deaconess Medical Center	OTHER
Brigham and Women's Hospital	OTHER

Description Module

Brief Summary

The purpose of this study is to collect information on what effects (good or bad) CT-2103 (Xyotax) has on breast cancer as well as any side effects the drug may cause.

Detailed Description

Patients will be given CT-2103 intravenously every 3 weeks. One week after the first dose of CT-2103 a physical exam, blood work and assessment of any side effects will be performed.
Prior to each injection of CT-2103, a physical exam, blood work and assessment of any side effects will be performed (every 3 weeks).
Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to determine whether the treatment is working.
Additional blood work will be performed once per week after the first two doses of CT-2103.
The participation in this study will last at least 2 cycles (6 weeks), however patients may remain on the study as long as there is no disease progression, and they are able to tolerate the study drug without severe side effects.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
CT-2103 (Xyotax)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage IV disease
Age greater than 18 years
At least one measurable target lesion as defined by RECIST that has not been previously treated with local therapy
HER2-negative breast cancer
Up to one prior chemotherapy for advanced or metastatic disease
ECOG performance status 0-1
Life expectancy > 12 weeks
Adequate liver and bone marrow function: AST < 2.5 x ULN; Bilirubin < 1.5 x ULN; ANC > 1,500/ul; platelet count > 100,000/ul; normal PT and PTT
At least 2 weeks since prior radiation and recovered from treatment-related toxicity

Exclusion Criteria:

Prior taxanes for treatment of metastatic disease
Pregnant of breast-feeding women
HER2-positive breast cancer
More than 1 prior chemotherapy regimen for metastatic disease
Untreated brain metastases
Concurrent radiotherapy or investigational drug
Prior bone marrow or stem cell transplant
History of other malignancy within the last 5 years, not including curatively-treated carcinoma in situ of the cervix or non-melanoma skin cancer
Uncontrolled infection
Active bleeding, or history of bleeding requiring transfusion
Active cardiac disease
Serious medical or psychiatric illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence N. Shulman, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beth Israel Deaconess Medical Center		Boston	Massachusetts	02115	United States
Dana-Farber Cancer Institute

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases