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Recurrent Non-small Cell Lung CancerPhase 2NCT00077350

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

A Phase 2 study testing triapine, gemcitabine hydrochloride and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Non-small Cell Lung Cancer
What is being tested?
triapine, gemcitabine hydrochloride and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
Jul 2004to Apr 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

SECONDARY OBJECTIVES:

  1. 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.

TERTIARY OBJECTIVES:

  1. 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 blocks.

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

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.

Being tested
triapine, gemcitabine hydrochloride, laboratory biomarker analysis
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • triapineDrug

    Also called 3-AP, OCX-191

    Given IV

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00077350
Study groupRoleWhat they receive
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.
Receives: Drug: triapine; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 1.5 years

Secondary outcomes (5)

  1. Rate of stable disease

    Measured: Up to 1.5 years

  2. Time to treatment progression

    Measured: Up to 1.5 years

  3. Duration of response

    Measured: Up to 1.5 years

  4. Overall survival

    Measured: Up to 1.5 years

  5. Toxicity using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

    Measured: Up to 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077350
Sponsor's protocol ID
NCI-2012-02971
Other IDs
E1503, U10CA021115, CDR0000350200
Status last verified
Feb 2013
First submitted
10 Feb 2004
Last updated
27 Feb 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing triapine, gemcitabine hydrochloride and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Up to 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00077350.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.

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