Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Cancer Therapeutics Research Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 1 2008

    Estimated Enrollment :

    31 Patients enrolled

    Trial Details

    Trial ID

    NCT00077415

    Start Date

    April 1 2004

    End Date

    February 1 2008

    Last Update

    May 15 2013

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, Australia, 2050

    2

    Sir Charles Gairdner Hospital - Perth

    Perth, Western Australia, Australia, 6009

    3

    Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

    4

    Cancer Institute at National University Hospital

    Singapore, Singapore, 119074