3-AP and Gemcitabine as Second-Line Therapy in Treating Patients With Stage III or Stage IV Recurrent Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Study Of Triapine® Alone Versus Triapine and Gemcitabine As Second-Line Treatment Of Advanced Non-Small-Cell-Lung Cancer In Patients Who Had Prior Gemcitabine With Evaluation Of The Effect Of Triapine® On Gemcitabine Pharmacokinetics and Cellular Uptake In Peripheral Mononuclear Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077415
• Other study ID #: CTRG-LUN012
• Secondary ID: CDR0000350313NCI
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2004
• Last updated: May 14, 2013
• Start date: April 2004
• Est. completion date: February 2008

Study information

• Verified date: August 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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 more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving 3-AP together with gemcitabine as second-line therapy works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.

Description:

OBJECTIVES:

Primary

• Determine the objective response rate in patients with stage III or IV recurrent non-small cell lung cancer treated with 3-AP (Triapine®) and gemcitabine as second-line therapy.

Secondary

• Determine the response duration, median time to progression, and overall survival of patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

• Determine the effect of 3-AP (Triapine®) on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to participating center.

Patients receive 3-AP (Triapine®) IV over 4 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.

NOTE: *For course 1 only, gemcitabine is administered alone on day 1 and in combination with 3-AP (Triapine®) on days 8 and 15.

Patients are followed every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 15-31 patients will be accrued for this study within 7.5-21 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed* non-small cell lung cancer (NSCLC)

• Stage III or IV disease

• One of the following cellular types:

• Adenocarcinoma

• Non-diffuse bronchoalveolar cell carcinoma

• Large cell carcinoma

• Squamous cell carcinoma NOTE: *A repeat biopsy of any accessible tumor site is required if > 5 years have elapsed since the initial diagnosis

• Progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for stage III or IV NSCLC and must have achieved, at least once, a partial response, complete response, or stable disease during therapy

• Not a primary non-responder and experienced only progressive disease during gemcitabine-containing chemotherapy

• Measurable disease

• At least 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10 mm by spiral CT scan

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC = 3,000/mm^3

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• No glucose-6-phosphate dehydrogenase (G6PD) deficiency

Hepatic

• Bilirubin = 1.5 times upper limit of normal (ULN)

• ALT = 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

• Creatinine = 1.5 times ULN OR

• Creatinine clearance = 50 mL/min

Cardiovascular

• No prior uncontrolled cardiac disease

• No myocardial infarction within the past 12 months

• No symptomatic congestive heart failure

• No coronary artery disease

• No cardiac arrhythmia

Pulmonary

• No uncontrolled symptomatic pulmonary disease

• No pulmonary disease that requires oxygen therapy

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except completely treated carcinoma in situ of the cervix or nonmelanoma skin cancer

• No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents

• No other concurrent uncontrolled illness

• No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent investigational agents

• No other concurrent anticancer agents or therapies

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• gemcitabine hydrochloride

• triapine

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital - Perth	Perth	Western Australia
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Korea, Republic of	Yonsei Cancer Center at Yonsei University Medical Center	Seoul
Singapore	Cancer Institute at National University Hospital	Singapore
Singapore	Johns Hopkins Singapore International Medical Centre	Singapore
Singapore	National Cancer Centre - Singapore	Singapore
Singapore	National University of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Therapeutics Research Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

Australia,  Hong Kong,  Korea, Republic of,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective tumor response as assessed by RECIST criteria			No
Secondary	Toxicity as assessed by NCI CTCAE v3.0			Yes
Secondary	Overall survival			No
Secondary	Median time to progression			No
Secondary	Duration of overall response			No
Secondary	Pharmacokinetics			No