S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00045162
First received: September 6, 2002
Last updated: July 3, 2013
Last verified: July 2013

September 6, 2002
July 3, 2013
November 2002
March 2008   (final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment. ] [ Designated as safety issue: No ]
Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Not Provided
Complete list of historical versions of study NCT00045162 on ClinicalTrials.gov Archive Site
  • Progression-free Survival [ Time Frame: Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment. ] [ Designated as safety issue: No ]
    Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.
  • Confirmed and Unconfirmed Complete and Partial Responses. [ Time Frame: Every 6 weeks while on protocol treatment for a maximum of 12 weeks ] [ Designated as safety issue: No ]
    Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.
  • Number of Patients With a Given Type and Grade of Adverse Event. [ Time Frame: Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks. ] [ Designated as safety issue: Yes ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.
Not Provided
Not Provided
Not Provided
 
S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer
Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.

OBJECTIVES:

  • Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide.
  • Compare the objective response rate and progression-free survival of patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients.
  • Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
  • Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 3 weeks.

Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this study within 4 years.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin

    Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles

    Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles

  • Drug: etoposide
    100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
  • Drug: irinotecan hydrochloride
    60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles
  • Active Comparator: 1
    Interventions:
    • Drug: cisplatin
    • Drug: irinotecan hydrochloride
  • Active Comparator: 2
    Interventions:
    • Drug: cisplatin
    • Drug: etoposide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
671
December 2009
March 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
  • Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam
  • Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN

Renal

  • Creatinine normal
  • Creatinine clearance at least 50 mL/min

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • HIV negative
  • No concurrent AIDS-related illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for SCLC
  • No filgrastim (G-CSF) within 24 hours of chemotherapy

Chemotherapy

  • No prior systemic chemotherapy for SCLC

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • At least 21 days since prior brain radiotherapy and recovered
  • No other prior radiotherapy for SCLC

Surgery

  • See Disease Characteristics
  • At least 21 days since prior thoracic or other major surgery and recovered

Other

  • No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00045162
CDR0000256908, S0124, S0124, S0124, U10CA032102
Yes
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • North Central Cancer Treatment Group
  • Cancer and Leukemia Group B
Principal Investigator: Ronald B. Natale, MD Cedars-Sinai Medical Center
Principal Investigator: David R. Gandara, MD University of California, Davis
Principal Investigator: Primo N. Lara, MD University of California, Davis
Principal Investigator: James R. Jett, MD Mayo Clinic
Principal Investigator: Jane Carleton, MD Don Monti Comprehensive Cancer Center at North Shore University Hospital
Southwest Oncology Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP