Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bronx, New York 10467


Purpose:

Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. This phase I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.


Study summary:

PRIMARY OBJECTIVES: I. The escalation portion of the study will determine the MTD of G3139/Cisplatin and will help determine the toxicities of this combination. II. Once the MTD is determined, an additional 12 patients will be enrolled in order to obtain a set of tumor biopsies for microarray analysis. SECONDARY OBJECTIVES: I. The collection of additional toxicity data for this combination OUTLINE: This is a pilot, multicenter, dose-escalation study of oblimersen. Phase I: Patients receive oblimersen IV continuously on days 1-7, fluorouracil IV continuously on days 4-8, and cisplatin IV 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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD. Phase II: Patients receive treatment as in phase I with oblimersen at the MTD. PROJECTED ACCRUAL: Approximately 37-97 patients (3-36 for phase I and 34-67 for phase II) will be accrued for this study within 15-18 months.


Criteria:

Inclusion Criteria: - Patients must have histologically or cytologically confirmed adenocarcinoma of the esophagus, gastro- esophageal junction, or stomach; patients with squamous cell carcinoma of the esophagus will also be eligible, as these have traditionally been grouped and treated the same as adenocarcinomas of the esophagus; patients must have locally advanced, recurrent or metastatic disease, not amenable to complete surgical resection or definitive radiation therapy - Patients participating in any portion of the study are not required to have measurable disease; clinically evaluable disease will suffice; the radiographic imaging required for study entry must be obtained within 3 weeks prior to start of therapy - Patients may have had prior surgery, radiation therapy, combined modality chemo- radiation, or at most one prior chemotherapy regimen for advanced, recurrent or metastatic disease; for patients who have received significant full dose chemotherapy (defined as at least 2 months of therapy) during their primary treatment (i.e. McDonald for adjuvant treatment of gastric cancer, or Herscovic for chemo- radiation of esophageal cancer) this will be considered a prior regimen of chemotherapy, unless at least 6 months have elapsed since completion of this treatment; if recurrence or progression occurs after 6 months from prior significant chemotherapy, another chemotherapeutic regimen may have been used prior to study entry; at least 3 weeks since the last administration of prior chemotherapy or radiation must have elapsed prior to commencing treatment on this study; 6 weeks if the last regimen included BCNU or mitomycin C; for patients on a weekly treatment regimen (e.g. weekly cisplatin/ irinotecan, weekly irinotecan/ PS341, weekly taxanes) patients may start treatment on protocol 2 weeks after the last dose of prior chemotherapy; for patients on treatment regimens given every 3 weeks, three weeks must have elapsed prior to initiating treatment on this protocol; hematologic recovery must be documented as outlined below - Life expectancy of greater than 12 weeks - ECOG performance status =<2 (Karnofsky >= 60%) - Absolute neutrophil count >= 1,500/uL - Platelets >= 100,000/uL - Total bilirubin within normal institutional limits - Creatinine =< 1.5 OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal - The effects of G3139 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because G3139 agents as well as other therapeutic agents used in this trial are known to be teratogenic, 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; 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 with accessible tumors are obliged to participate in biopsies 1 and 2; accessible tumors are defined as tumors reachable by EGD, or metastases, which, in the opinion of the treating physician can be biopsied with commonly utilized biopsy methods (such as CT guided biopsy); biopsy #3 on day 6 is optional; patients who do not have have accessible tumor tissue may participate in the study if at least one tumor deposit is measurable Exclusion Criteria: - Patients who have had chemotherapy or radiotherapy within 21 days (6 weeks for nitrosoureas or mitomycin C, two weeks if prior treatment was a weekly regimen) prior to entering the study or those who have not recovered from adverse events (grade 2 or worse) due to agents administered earlier - Patients who have had photodynamic therapy within 4 weeks of proposed study entry will be excluded; patients will be allowed to receive concurrent photodynamic therapy for obstruction untreatable by stent, laser, or dilation; patients who do require concurrent photodynamic therapy and who are participating in the serial biopsy portion of the study must wait until after cycle 1 and its biopsies are completed - 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 anti- sense oligonucleotides, cisplatin, fluorouracil or other agents used in the study - Patients may not have received G3139 previously - 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 because G3139 is an anti- sense oligonucleotide agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with G3139, breastfeeding should be discontinued if the mother is treated with G3139; these potential risks may also apply to other agents used in this study - Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with G3139 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated


NCT ID:

NCT00064259


Primary Contact:

Principal Investigator
Andreas Kaubisch
Montefiore Medical Center


Backup Contact:

N/A


Location Contact:

Bronx, New York 10467
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.