Combination Chemotherapy Plus Oblimersen in Treating Patients With Advanced Solid Tumors
A Phase I Study of Antisense Bcl-2 Oligonucleotide (G3139) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumors
5 other identifiers
interventional
55
1 country
1
Brief Summary
Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 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
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 5, 2003
CompletedFirst Posted
Study publicly available on registry
February 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedMay 16, 2013
May 1, 2013
5.6 years
February 5, 2003
May 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD) defined as the highest safely tolerated dose where at most 1 patient experiences a dose-limiting toxicities (DLT) and the next higher dose having at least 2 patients who experience DLT
21 days
Secondary Outcomes (2)
Pharmacokinetic parameters of G3139 in combination with paclitaxel and carboplatin
Day 1, 4, 5, and 6 of course 1
Disease response as having either progressive disease (PD), stable disease (SD), a partial response (PR), or a complete response (CR)
Up to 6 years
Study Arms (1)
Treatment (oblimersen sodium, paclitaxel)
EXPERIMENTALPatients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD.
Interventions
Given IV
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed solid malignancy that is metastatic or unresectable and for which no standard curative therapy exists; patients with lymphoma are excluded
- ECOG performance status 0, 1, or 2 (Karnofsky \>= 60%)
- Life expectancy of greater than 3 months
- Leukocytes \>= 3,000/mm\^3
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelets \>= 100,000/mm\^3
- 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 m\^2 for patients with creatinine levels above institutional normal
- 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, for the duration of study participation, and for three months after discontinuation of treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Patients will need to have a central line or nurse-placed PICC line in place prior to treatment on the protocol
You may not qualify if:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- Patients with known brain metastases will be excluded from this clinical trial
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to G3139 or other agents used in study, unless approved by investigator
- No pre-existing grade \>= 2 neuropathy
- No personal history of a bleeding diathesis given potential significant antiplatelet effects of therapy
- 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
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with G3139
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Wilding
University of Wisconsin, Madison
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
February 5, 2003
First Posted
February 6, 2003
Study Start
October 1, 2002
Primary Completion
May 1, 2008
Last Updated
May 16, 2013
Record last verified: 2013-05