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

Breast Cancer Clinical Trial

Official title:

Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00148707
• Other study ID #: 04-299
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: December 19, 2007
• Start date: October 2004
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• CT-2103 (Xyotax)

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.
Secondary	To evaluate the side effects of CT-2103 in patients with metastatic breast cancer
Secondary	to evaluate the proportion of patients that have complete or partial response or stable disease at 4 months
Secondary	to determine the time to progression and overall survival of patients treated with CT2103.