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 is currently recruiting patients.
Sponsored by: |
Cancer Therapeutics Research Group
|
Information provided by: |
National Cancer Institute (NCI) |
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of 3-AP in combination with gemcitabine as second-line therapy in treating
patients who have recurrent stage III or stage IV non-small cell lung cancer.
Condition
|
Treatment or Intervention |
Phase |
Non-small cell lung cancer
|
Drug: 3-AP Drug: gemcitabine Procedure: chemosensitization/potentiation Procedure: chemotherapy
|
Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer; Respiratory Diseases
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 3-AP (Triapine®) and Gemcitabine as Second-Line Therapy for Patients With Stage III or IV Recurrent Non-Small
Cell Lung Cancer
Further Study Details:
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 above,
Genders Eligible for Study:
Both
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
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
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 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
Chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
Surgery
Other
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Location
and Contact
Information
Australia, New South Wales Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney,
New South Wales,
2050,
Australia; Recruiting
Michael Boyer
61-2-9515-5494
Hong Kong Prince of Wales Hospital, Shatin, New Territories,
Hong Kong; Recruiting
Brigette Ma, MD
852-2632-2989
Korea, Republic of Yonsei Cancer Center, Seoul,
120-752,
Korea, Republic of; Recruiting
Singapore Cancer Institute at National University Hospital, Singapore,
119074,
Singapore; Recruiting
Johns Hopkins - Singapore, Singapore,
119074,
Singapore; Recruiting
National Cancer Centre - Singapore, Singapore,
169610,
Singapore; Recruiting
National University of Singapore, Singapore,
119260,
Singapore; Recruiting
Theresa Tan
65-6874-3685
Study chairs or principal investigators
Brigette Ma, MD, Study Chair, Prince of Wales Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000350313; CTRG-LUN012; NCI-6256
Record last reviewed:
August 2004
Record first received:
February 10, 2004
ClinicalTrials.gov Identifier:
NCT00077415Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-29