NCT00270907

Brief Summary

The goal of this phase I clinical study is to find the highest safe dose of gemcitabine and CT-2103 that can be given in combination for the treatment of metastatic breast cancer. The safety and effectiveness of this combination will also be studied. This clinical trial will be offered to patients who are being considered for treatment with gemcitabine. Research lab samples and research biopsies will not be requested as part of this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2005

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

6.8 years

First QC Date

December 28, 2005

Last Update Submit

February 11, 2013

Conditions

Metastatic Breast CancerBreast Cancer

Keywords

Metastatic Breast CancerBreast CancerCT-2103GemcitabineXyotaxGemzar

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of CT-2103

    MTD defined as the level of CT-2103 at which 2 out of 6 patients had dose limiting toxicity (DLT) where the primary DLT events of CT-2103 are uncomplicated neutropenia, febrile neutropenia, and/or grade 3 neuropathy. Assessments during the first cycle of therapy, where cycle is 21 days.

    21 days

Secondary Outcomes (1)

  • Number of Participants with Response

    6 weeks following chemotherapy

Study Arms (1)

CT-2103 + Gemcitabine

EXPERIMENTAL

CT-2103 135 mg/m\^2 intravenous (IV) on Day 1. Gemcitabine 1000 mg/m\^2 IV on Day 1 and 8.

Drug: CT-2103Drug: Gemcitabine

Interventions

CT-2103DRUG

135 mg/m\^2 IV on Day 1.

Also known as: Xyotax
CT-2103 + Gemcitabine
GemcitabineDRUG

1000 mg/m\^2 IV on Day 1 and 8.

Also known as: Gemzar
CT-2103 + Gemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically confirmed breast cancer that is either metastatic or unresectable.
  • Patients must have received anthracyclines as treatment of either early stage or metastatic breast cancer.
  • Previous taxane therapy is allowed.
  • Age \>/= 18 years. There is limited data regarding the use of CT-2103 in children under 18 and they will be excluded from this combination dose finding study.
  • Eastern Cooperative Oncology Group (ECOG) performance status \</= 2 (Karnofsky \>/= 60%).
  • Measurable disease is not required.
  • Previous endocrine therapies are allowed but should be discontinued prior to initiation of therapy.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.
  • The effects of CT-2103 on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Females of childbearing potential are defined as females who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 months.
  • Patients must have normal organ and marrow function as defined below: leukocytes \>/= 3,000/ul; absolute neutrophil count \>/= 1,500/ul; platelets \>/= 100,000/ul; total bilirubin within normal institutional limits; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \</= 2.5 \* institutional upper limit of normal; creatinine within normal institutional limits or creatinine clearance \>/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; coagulation prothrombin time (PT) and Partial thromboplastin time (PTT) within normal limits unless patients are already anti-coagulated for other reasons (i.e., atrial fibrillation, etc.).
  • Patients with Her-2/neu positive tumors should have received prior trastuzumab if clinically appropriate.

You may not qualify if:

  • Patients with preexisting neuropathy \>/= grade 2.
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CT-2103, gemcitabine or other agents used in study. History of typical paclitaxel- or docetaxel-induced Grade 1-2 hypersensitivity reactions is permitted.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study.
  • Previous history of stem cell transplantation.
  • History of central nervous system metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

paclitaxel poliglumexGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Marjorie Green, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2005

First Posted

December 29, 2005

Study Start

December 1, 2005

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

US(1)