A Phase II Trial of Triapine (NSC #663249) in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. Giving 3-AP together with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with gemcitabine works as second-line therapy in treating patients with progressive or recurrent non-small cell lung cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed non-small cell lung cancer (NSCLC); cytology alone is not acceptable

• Patients must have progressive or recurrent NSCLC, and must have failed one and only one prior cytotoxic chemotherapy regimen for advanced disease; patients must not have received prior gemcitabine chemotherapy

• Patients must have measurable disease, as defined by RECIST, within 4 weeks prior to registration

• Patients must have an ECOG performance status of 0 or 1

• Bilirubin < 1.5 x upper limit of normal

• AST (SGOT) < 3 x upper limit of normal

• Serum creatinine =< 1.5 mg/dL, or calculated creatinine clearance >= 60 mL/min

• Absolute granulocyte count >= 1500/mm3 and WBC >= 3000/mm^3

• Hemoglobin >= 9 g/L

• Platelet count >= 100,000/mm^3

• Patients must have completed any radiation therapy >= 3 weeks prior to registration

• Patients must have completed prior cytotoxic chemotherapy >= 3 weeks prior to registration and have recovered from adverse effects from the chemotherapy to =< Grade 1, or baseline

• Patients with brain metastases which have been treated are eligible if the patient is > 3 weeks post completion of treatment for their brain metastases, and patient is neurologically stable; patients with previous brain metastases who have not yet received therapy specifically intended for their brain metastases are not eligible to enroll in this protocol

• Life expectancy greater than 3 months

• 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®; women must not be pregnant or breastfeeding due to the absence of information regarding the use of these agents in these populations; a negative serum pregnancy test is required within 14 days of study entry; 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 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

• Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination antiretroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Triapine®

• Patients must not have an active second malignancy

• Patients must not have, at the time of registration, uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements; furthermore, since hypoxemia may cause serious adverse events in persons with serious cardiac and/or pulmonary disease, patients at the time of registration with a history of myocardial infarction within the prior 6 months, or with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring medical intervention (with the exception of chronic, stable, asymptomatic atrial fibrillation), or pulmonary disease requiring oxygen are excluded

• Patients must not have dementia or active psychosis

• Patients must not have used any investigational agent in the month before study enrollment

• Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Triapine® or other agents used in this study

• Patients must not have a clinical history of G6PD (glucose-6-phosphate dehydrogenase) deficiency; persons at high risk for this condition (patients of African, Asian, or Mediterranean origin/ancestry) must undergo specific clinical testing at protocol entry for this condition; patients testing positive for G6PD deficiency are excluded from protocol entry