GTI-2040, Oxaliplatin, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer or Other Solid Tumors
A Phase I Study of GTI-2040 in Combination With Oxaliplatin and Capecitabine in Patients With Advanced Metastatic Solid Tumors
4 other identifiers
interventional
20
1 country
1
Brief Summary
This phase I trial is studying the side effects and best dose of capecitabine when given together with GTI-2040 and oxaliplatin in treating patients with locally advanced or metastatic colorectal cancer or other solid tumors. Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. Giving GTI-2040 together with oxaliplatin and capecitabine may kill more tumor cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 10, 2004
CompletedFirst Posted
Study publicly available on registry
June 11, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedMarch 27, 2013
January 1, 2013
3.9 years
June 10, 2004
March 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
MTD of the combination of GTI-2040, oxaliplatin and capecitabine based on the incidence of dose-limiting toxicity (DLT) as assessed by CTCAE version 3.0
Adverse events will be summarized by grade, attribution, and organ system. Hematological and clinical chemistry laboratory results will be included in the adverse event summary.
21 days
Secondary Outcomes (3)
Objective response (confirmed PR and CR) according to RECIST
At 6 weeks
Pharmacokinetics
At baseline, and at 7 and 14 days after the start of infusion
Change in biochemical and molecular correlates
From baseline to up to 4 years
Study Arms (1)
Treatment (GTI-2040, capecitabine, oxaliplatin)
EXPERIMENTALPatients receive GTI-2040 IV continuously on days 1-14, oral capecitabine twice daily on days 2-15, and oxaliplatin IV over 2 hours on day 2 of the first course. In all subsequent courses, capecitabine is administered on days 1-14, oxaliplatin is administered on day 1, and GTI-2040 is administered as in course 1. Courses repeat every 21 days in the absence of disease progression and unacceptable toxicity.
Interventions
Given IV
Given orally
Correlative studies
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have locally advanced or metastatic colorectal cancer that is not amenable to surgical treatment; selected patients with advanced disease in incurable cancers of other types may be considered
- Patients must have histological or cytological proof of malignancy
- Patients must have had at least one standard prior chemotherapy for locally advanced or metastatic disease with no prior oxaliplatin containing regimen; patients who relapse within 12 months of adjuvant therapy are eligible
- Karnofsky performance status of \>= 60%
- Absolute neutrophil count \> 1500/ul
- Platelets \> 100,000/ul
- Total bilirubin within institutional normal limits
- AST (SGOT)/ALT (SGPT) within 2.5 x institutional normal limits
- Alkaline phosphatase within 2.5x institutional normal limits
- Creatinine within institutional normal limits or a calculated creatinine clearance \> 60 ml/min
- Patients should have no greater than grade 1 neuropathy (CTCAE v3.0)
- Ability to understand and the willingness to sign a written IRB approved consent document
- Measurable disease not required
- Previous chemotherapy must have been completed \> 21 days before treatment on this study (\> 6 weeks for mitomycin-c or nitrosoureas)
- Life expectancy of at least 12 weeks
You may not qualify if:
- Active or chronic hepatitis B or C
- HIV positive patients receiving antiviral therapy because of possible pharmacokinetic interactions
- Uncontrolled intercurrent illnesses including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia
- Pregnant or nursing women are excluded due to the potential for teratogenic effects and for potential deleterious effects on the infant; woman of childbearing age and men must practice an effective form of contraception
- Patients with known brain metastasis are excluded due their poor prognosis and due to possible neurologic sequelae that could confound the evaluation of the investigational treatment
- Patients requiring anticoagulation are excluded as polyanions are known to inhibit clotting mechanisms and phosphorothioate oligonucleotide may act in a similar mechanism; patients receiving low dose prophylactic Coumadin (1 mg/day) may be included
- Medical, social, of psychological factors that would interfere with consent and follow-up
- Patients with a diagnosis of pulmonary fibrosis or a pulmonary interstitial process
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Shibata
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2004
First Posted
June 11, 2004
Study Start
May 1, 2004
Primary Completion
April 1, 2008
Last Updated
March 27, 2013
Record last verified: 2013-01