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
4 other identifiers
interventional
48
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2004
CompletedFirst Posted
Study publicly available on registry
February 12, 2004
CompletedStudy Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedFebruary 27, 2013
February 1, 2013
9 months
February 10, 2004
February 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
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.
Up to 1.5 years
Secondary Outcomes (5)
Rate of stable disease
Up to 1.5 years
Time to treatment progression
Up to 1.5 years
Duration of response
Up to 1.5 years
Overall survival
Up to 1.5 years
Toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Up to 1.5 years
Study Arms (1)
Treatment (triapine and gemcitabine hydrochloride)
EXPERIMENTALPatients 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.
Interventions
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Traynor
Eastern Cooperative Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2004
First Posted
February 12, 2004
Study Start
July 1, 2004
Primary Completion
April 1, 2005
Last Updated
February 27, 2013
Record last verified: 2013-02