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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: tirapazamine
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: October 2000
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006487

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, United States, 85012
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
Veterans Affairs Medical Center - Long Beach
Long Beach, California, United States, 90822
Cancer Center and Beckman Research Institute, City of Hope
Los Angeles, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California Davis Cancer Center
Sacramento, California, United States, 95817
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Stanford University
Stanford, California, United States, 94305
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40511-1093
United States, Louisiana
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71130
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Providence Hospital - Southfield
Southfield, Michigan, United States, 48075-9975
United States, Mississippi
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States, 39531-2410
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States, 64128
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
CCOP - Columbus
Columbus, Ohio, United States, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
CCOP - Dayton
Kettering, Ohio, United States, 45429
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
Oregon Cancer Center
Portland, Oregon, United States, 97201-3098
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Veterans Affairs Medical Center - Dallas
Dallas, Texas, United States, 75216
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79423
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Quynh-Thu X. Le, MD Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006487     History of Changes
Other Study ID Numbers: CDR0000068318, U10CA032102, S0004
Study First Received: November 6, 2000
Last Updated: October 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
limited stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Tirapazamine
Cisplatin
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 24, 2014