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S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006487
First received: November 6, 2000
Last updated: October 3, 2012
Last verified: October 2012

November 6, 2000
October 3, 2012
October 2000
July 2004   (final data collection date for primary outcome measure)
Feasibility and Toxicity [ Time Frame: toxicity is assessed weekly ] [ Designated as safety issue: Yes ]
If ten or more patients experience either Grade 3 or greater esophagitis or pneumonitis at any dose level, the trial will be stopped. Nine or fewer patients experiencing either of these toxicities will be evidence that the dose can be escalated to the next level.
Not Provided
Complete list of historical versions of study NCT00006487 on ClinicalTrials.gov Archive Site
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S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.

OBJECTIVES:

  • Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer.
  • Determine the toxicities of this treatment regimen in these patients.
  • Determine the response rate in these patients treated with this regimen.

OUTLINE: Patients are assigned to one of two induction therapy arms.

  • Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1.
  • Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm I.

Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.

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

PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: cisplatin

    During induction: 50 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion

    During consolidation: 60 mg/m2, IV on Day 1 only at approximately Week 11, Week 14. 1 hour infusion.

    Other Name: platinol
  • Drug: etoposide

    During induction: 50 mg/m2/day, IV on Days 1 - 5, 29 - 33. 1 hour infusion

    During consolidation: 120 mg/m2, IV on Days 1, 2 and 3 at approximately Week 11, Week 14. 1 hour infusion.

    Other Name: VP-16
  • Drug: tirapazamine

    During induction:

    Phase I low dose: 260 mg/m2/day, IV on Days 1, 8, 29, 36. 1 hour infusion

    Phase II high dose: 330 mg/m2/day, IV on Days 1, 8, 29, 36 1 hour infusion

    During consolidation:

    330 mg/ m2, IV Day 1 only at approximately Week 11, Week 14. 1 hour infusion.

  • Radiation: radiation therapy
    Radiotherapy should begin within 1 - 3 hours after completion of TPZ infusion on Day 1 of Cycle 1 of induction chemotherapy as outlined above. Computed tomography based treatment planning is strongly recommended.The primary tumor, adjacent mediastinum and other targeted lymph nodes shall receive 4,500 cGy in 25 fractions, five days/week at 180 cGy daily. A 1,600 cGy boost to areas of gross disease will be delivered through reduced off-spinal cord fields in eight fractions, five days/week at 200 cGy daily.
Active Comparator: chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
Interventions:
  • Drug: cisplatin
  • Drug: etoposide
  • Drug: tirapazamine
  • Radiation: radiation therapy
Le QT, McCoy J, Williamson S, Ryu J, Gaspar LE, Edelman MJ, Dakhil SR, Sides SD, Crowley JJ, Gandara DR; Southwest oncology group. Phase I study of tirapazamine plus cisplatin/etoposide and concurrent thoracic radiotherapy in limited-stage small cell lung cancer (S0004): a Southwest Oncology Group study. Clin Cancer Res. 2004 Aug 15;10(16):5418-24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2004
July 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)
  • No malignant pericardial or pleural effusions, including any of the following:

    • Cytologically positive effusions
    • Exudative effusions not attributable to other etiologies
  • No brain metastases
  • Disease (measurable or non-measurable) must be present outside the area of prior surgical resection

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN

Renal:

  • Creatinine no greater than ULN OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No symptomatic sensory neuropathy grade 1 or greater
  • No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission
  • No other medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for SCLC

Chemotherapy:

  • No prior systemic chemotherapy for SCLC

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior thoracic radiotherapy for SCLC

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior thoracic or other major surgery and recovered
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006487
CDR0000068318, U10CA032102, S0004
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Quynh-Thu X. Le, MD Stanford University
Southwest Oncology Group
October 2012

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