Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	ALPHA-A1-99002L NCT00054392

Objectives

1. Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin.
2. Compare the overall response rate and time to progression in patients treated with these regimens.
3. Compare the toxic effects of these regimens in these patients.
4. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types:
  • Squamous cell
  • Adenocarcinoma
  • Large cell anaplastic
  • Bronchoalveolar
  • Non-small cell carcinoma not otherwise specified

   [Note: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)]




• Evidence of at least 1 of the following:
  • Clinically documented recurrent disease after prior radiation or surgery
  • Stage IV disease (distant metastases)
  • Stage IIIB disease presenting with 1 of the following:
    • Pleural or pericardial effusion by CT scan or chest x-ray
    • Pleural implants documented pathologically or seen on CT scan or x-ray



• Measurable or evaluable disease



• No brain metastases unless clinically stable after surgery and/or radiotherapy

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for advanced NSCLC

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• Recovered from prior radiotherapy
• No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology
• No concurrent radiotherapy (except for brain metastases)

Surgery

• See Disease Characteristics

Other

• No concurrent aminoglycoside antibiotics

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST less than 5 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 40 mL/min

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)

Expected Enrollment

A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.

Outcomes

Survival

Tumor response rate
Time to disease progression
Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter

Outline

This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.



• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.



• Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.

In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented.

Patients are followed every 3 months.

Treat J, Belani CP, Edelman MJ, et al.: A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): update of the Alpha Oncology trial (A1-99002L). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7025, 627s, 2005.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center CCOP Research Base

Joseph Treat, MD, Protocol chair		Ph: 215-707-8030

Registry Information
Official Title		A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
Trial Start Date		2001-09-14
Registered in ClinicalTrials.gov		NCT00054392
Date Submitted to PDQ		2002-12-31
Information Last Verified		2006-12-13
NCI Grant/Contract Number		CA16056

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