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

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer

Thank you

Trial Information

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


I. To evaluate the antitumor response rate (by tumor measurement per the RECIST criteria) in
patients taking this combination in the setting of second line treatment for NSCLC.


I. To evaluate the rate of stable disease, time to treatment progression, duration of
response, and survival of patients taking this combination treatment.

II. To estimate the safety and tolerability of this combination in this phase II trial of
patients with relapsed NSCLC.


I. To evaluate the potential effects of MDR polymorphisms in patients taking Triapine® in
this combination.

II. To evaluate the effect of Triapine® and gemcitabine on RRM1, RRM2, and p53R2 protein
expression per IHC and gene expression per RT-PCR from baseline diagnostic paraffin embedded

III. To evaluate both germline (peripheral blood) and tumor DNA for the presence of p53

OUTLINE: This is a multicenter study.

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.

Patients are followed for up to 1.5 years.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome 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.

Outcome Time Frame:

Up to 1.5 years

Safety Issue:


Principal Investigator

Anne Traynor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Eastern Cooperative Oncology Group Boston, Massachusetts  02215