CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Cell Therapeutics
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00270907
First received: December 28, 2005
Last updated: October 18, 2011
Last verified: October 2011
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Purpose
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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.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer Breast Cancer |
Drug: CT-2103 Drug: Gemcitabine |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase I Study of CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: During the first cycle of therapy, where cycle is 21 days. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluation of response in patients with measurable disease. [ Time Frame: After each 6 weeks of chemotherapy ] [ Designated as safety issue: No ]
Estimated Enrollment: | 18 |
Study Start Date: | December 2005 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: CT-2103 + Gemcitabine |
Drug: CT-2103
135 mg/m^2 IV on Day 1.
Other Name: Xyotax
Drug: Gemcitabine
1000 mg/m^2 IV on Day 1 and 8.
Other Name: Gemzar
|
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Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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; AST(SGOT)/ALT(SGPT) </= 2.5 X 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 PT and 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.
Exclusion Criteria:
- 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.
- While there is no strict exclusion based upon previous number of therapies, patients who experienced grade 3 or 4 hematologic toxicity requiring the use of WBC growth factor support during their most recent chemotherapy prior to enrollment are excluded. Exceptions to this would include patients who received growth factor support as mandated by a clinical study, and/or patients who have been off all chemotherapy for at least 6 months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270907
Locations
United States, Texas | |
UT MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cell Therapeutics
Investigators
Principal Investigator: | Marjorie Green, MD | M.D. Anderson Cancer Center |
More Information
No publications provided
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00270907 History of Changes |
Other Study ID Numbers: | 2005-0133 |
Study First Received: | December 28, 2005 |
Last Updated: | October 18, 2011 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
Metastatic Breast Cancer Breast Cancer CT-2103 |
Gemcitabine Xyotax Gemzar |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on October 16, 2012