3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077350

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Lung Cancer	Drug: gemcitabine hydrochloride Drug: triapine	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial of Triapine (NSC #663249) in Combination With Gemcitabine as Second Line Treatment of Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the antitumor response rate in patients with progressive or recurrent non-small cell lung cancer receiving 3-AP (Triapine^®) and gemcitabine as second-line treatment.

Secondary

Determine the rate of stable disease in patients treated with this regimen.
Determine the time to treatment progression in patients treated with this regimen.
Determine the duration of response in patients treated with this regimen.
Determine the survival of patients treated with this regimen.
Assess the safety and tolerability of this regimen in these patients.

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.

PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study within 5 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer
- Progressive or recurrent disease
Failed 1, and only 1, prior cytotoxic chemotherapy regimen for advanced disease
Measurable disease
Prior brain metastases allowed provided the following are true:
- More than 3 weeks since prior therapy for brain metastases
- Neurologically stable

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

More than 3 months

Hematopoietic

Absolute granulocyte count at least 1,500/mm^3
Hemoglobin at least 9 g/dL
Platelet count at least 100,000/mm^3
WBC at least 3,000/mm^3
No G6PD deficiency (for patients of African, Asian, or Mediterranean origin or ancestry)

Hepatic

AST less than 3 times upper limit of normal (ULN)
Bilirubin less than 1.5 times ULN

Renal

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular

No myocardial infarction within the past 6 months
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia requiring medical intervention
- Patients with chronic, stable, asymptomatic atrial fibrillation allowed

Pulmonary

No pulmonary disease requiring oxygen

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other concurrent uncontrolled illness
No ongoing or active infection
No prior allergic reactions to compounds of similar chemical or biological composition to 3-AP (Triapine^®) or other study agents
No psychiatric illness or social situation that would preclude study compliance
No dementia or active psychosis
No active second malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics
No prior gemcitabine
At least 3 weeks since prior cytotoxic chemotherapy and recovered

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
At least 3 weeks since prior radiotherapy

Surgery

See Disease Characteristics

Other

More than 1 month since prior investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077350

Show 86 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Anne M. Traynor, MD	University of Wisconsin, Madison
Investigator:	Julie Brahmer, MD	Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

Traynor AM, Levy DE, Bayer GK, et al.: ECOG 1503: a phase II trial of triapine (NSC#663249) with gemcitabine (T/G) as 2nd line treatment of non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 24 (Suppl 18): A-17151, 679s, 2006.

Study ID Numbers:	CDR0000350200, ECOG-E1503
Study First Received:	February 10, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00077350
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Gemcitabine
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009