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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077415
First received: February 10, 2004
Last updated: May 14, 2013
Last verified: August 2006
  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 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.


Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: triapine
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective tumor response as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Median time to progression [ Designated as safety issue: No ]
  • Duration of overall response [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: April 2004
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077415

Locations
Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of, 120-752
Singapore
Cancer Institute at National University Hospital
Singapore, Singapore, 119074
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433
National Cancer Centre - Singapore
Singapore, Singapore, 169610
National University of Singapore
Singapore, Singapore, 119260
Sponsors and Collaborators
Cancer Therapeutics Research Group
Investigators
Study Chair: Brigette Ma, MD Prince of Wales Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00077415     History of Changes
Other Study ID Numbers: CTRG-LUN012, CDR0000350313, NCI-6256
Study First Received: February 10, 2004
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014