Expired Study
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Bronx, New York 10467


Purpose:

This phase II trial is studying how well giving 3-AP together with gemcitabine works in treating patients with unresectable or metastatic bile duct or gallbladder cancer. Drugs used in chemotherapy, such as 3-AP and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help gemcitabine kill more cancer cells by making them more sensitive to the drug.


Study summary:

OBJECTIVES: I. To determine the objective response rates for the combination of triapine and gemcitabine in patients with primary tumors of the biliary ducts and gall bladder. II. To assess the toxicities and recovery from toxicities for patients with bilary duct and gall bladder tumors treated with the combination of triapine and gemcitabine. III. To determine the survival and progression free survival of patients with biliary and gall bladder tumors treated with the combination of triapine and gemcitabine. OUTLINE: This is a non-randomized, multicenter study. Patients are stratified according to bilirubin levels (normal vs abnormal). Patients receive 3-AP (Triapine) IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients are followed every 3 months for up to 2 years.


Criteria:

Inclusion Criteria: - Patients must have histologically or cytologically confirmed adenocarcinoma of the biliary ducts that is unresectable and/or metastatic; this can include unresectable or metastatic carcinomas of the Ampulla of Vater. In addition, unresectable or metastatic gall bladder carcinoma will be allowed - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension with the longest diameter to be recorded as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan - Patients may not have had prior chemotherapy for their disease; if patients have had prior definitive surgery or prior radiation therapy, they must have fully recovered from the effects of therapy with at least 4 weeks recovery time; for patients who have had surgical biopsy only, they must have simply recovered - Life expectancy of greater than 3 months - ECOG performance status =< 2 (Karnofsky >= 60%) - Leukocytes >= 3,000/uL - Absolute neutrophil count >= 1,500/uL - Platelets >= 100,000/uL - Creatinine within normal institutional limits - Patients may have mildly abnormal liver function defined as a total bilirubin > ULN and =< 3x the institutional upper limits of normal (includes CTCAE v.3 grades 1-2 hyperbilirubinemia) - The effects of Triapine on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because heterocyclic carboxaldehyde thiosemicarbazones as well as other therapeutic agents 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 - When possible, patients should have an aspiration of the tumor before beginning treatment and 24 hours after treatment has started - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - 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 Triapine or gemcitabine - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia - Uncontrolled pulmonary disease including asthma, chronic bronchitis and COPD or with requirements for chronic oxygen use - Pregnant women are excluded from this study because Triapine is a heterocyclic carboxaldehyde thiosemicarbazone 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 Triapine, breastfeeding should be discontinued if the mother is treated with Triapine; 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 Triapine or gemcitabine administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated - Patients with G6PD deficiency will be excluded in view of the potential for methemoglobinemia - Psychiatric illness/social situations that would limit compliance with study requirements


NCT ID:

NCT00075504


Primary Contact:

Principal Investigator
Allyson Ocean
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 12, 2017

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