Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI CTRG-LUN012 NCI-6256

Objectives

Primary

1. 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

1. Determine the response duration, median time to progression, and overall survival of patients treated with this regimen.
2. Determine the toxicity of this regimen in these patients.
3. Determine the effect of 3-AP (Triapine®) on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Projected Accrual

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

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Cancer Therapeutics Research Group

Brigette Ma, MD, Protocol chair		Ph: 852-2632-2989

Australia
New South Wales
	Sydney
	Sydney Cancer Centre at Royal Prince Alfred Hospital
		Michael Boyer	Ph:  61-2-9515-5494
Hong Kong
	Shatin, New Territories
	Prince of Wales Hospital
		Brigette Ma, MD	Ph:  852-2632-2989
		K. C. Lam	Ph:  852-2632-2119
Republic of Korea
	Seoul
	Yonsei Cancer Center
		Jae Kyung Roh, MD	Ph:  82-2-361-7618
			Email: jkroh@yumc.yonsei.ac.kr
Republic of Singapore
	Singapore
	Cancer Institute at National University Hospital
		Ross Soo, MD	Ph:  65-6772-4621
			Email: soolk@nuh.com.sg
	Johns Hopkins - Singapore
		Alex Yuang-Chi Chang, MD	Ph:  65-6777-2570
			Email: alexchang@jhnuh.com.sg
	National Cancer Centre - Singapore
		Tan Eng Huat, MD	Ph:  65-6-436-8171
			Email: dmoteh@nccs.com.sq
	National University of Singapore
		Theresa Tan	Ph:  65-6874-3685

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