Clinical trial · Interventional
A Phase II Trial of Triapine (NSC #663249) in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer
A Phase II Trial of Triapine® (NSC #663249) in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| triapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (triapine and gemcitabine hydrochloride)
- description
- Patients receive 3-AP (Triapine\^®) IV over 2 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: triapine
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- Up to 1.5 years
- description
- A true objective response rate of at least 25% will be considered evidence for further exploration of this regimen. A true response rate less than or equal to 5% will be considered evidence of minimal activity not worthy of further study.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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