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

NCT00077415 | Completed Phase 2

• 3 other identifiers: CTRG-LUN012CDR0000350313NCI-6256
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 8

Brief 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.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response as assessed by RECIST criteria

Secondary Outcomes (5)

• Toxicity as assessed by NCI CTCAE v3.0

• Overall survival

• Median time to progression

• Duration of overall response

• Pharmacokinetics

Interventions

gemcitabine hydrochloride DRUG

triapine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Therapeutics Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Cancer Institute at National University Hospital

Singapore, 119074, Singapore

Location

National University of Singapore

Singapore, 119260, Singapore

Location

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

Johns Hopkins Singapore International Medical Centre

Singapore, 308433, Singapore

Location

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Gemcitabine; 3-aminopyridine-2-carboxaldehyde thiosemicarbazone

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Brigette Ma, MD

  Prince of Wales Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: April 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 15, 2013

Record last verified: 2006-08

Locations

SG (4); HK (1); AU (2); KR (1)