Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00016367
First received: May 6, 2001
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: Trastuzumab
Drug: Cisplatin
Drug: Gemcitabine Hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multidose, Single Arm, Multicenter Clinical Trial of Cisplatin and Gemcitabine in Combination With Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in Patients Who Have Untreated p185HER2 Overexpressing Advanced Local Stage (Stage IIIb Pleural Effusion Only) and Metastatic (Stage IV) Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Efficacy of Cisplatin, Gemcitabine, + Trastuzumab in Untreated p185-HER2 Overexpressing Stage IIIB or IV Non-small Cell Lung Cancer [ Time Frame: 21 days cycles for 6 courses ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2001
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A
Gemcitabine IV followed by Cisplatin IV Day 1 and Trastuzumab (Herceptin) IV Day 2; Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15.
Biological: Trastuzumab

Regimen A: Trastuzumab IV over 90 minutes on days 2 and 8.

Regimen B: Trastuzumab IV over 30-90 minutes on days 1, 8 and 15.

Other Name: Herceptin
Drug: Cisplatin

Regimen A: Cisplatin IV over 2 hours on day 1 following gemcitabine.

Regimen B: Cisplatin IV over 2 hours on day 1.

Other Names:
  • Platinol
  • Platinol-AQ
  • CDDP
Drug: Gemcitabine Hydrochloride

Regimen A: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.

Regimen B: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.

Other Names:
  • Gemzar
  • Gemcitabine
Experimental: Regimen B
Starting Day 22 of regimen A, Trastuzumab IV, Gemcitabine IV, and Cisplatin IV Day 1. Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Repeats every 21 days for up to 5 courses.
Biological: Trastuzumab

Regimen A: Trastuzumab IV over 90 minutes on days 2 and 8.

Regimen B: Trastuzumab IV over 30-90 minutes on days 1, 8 and 15.

Other Name: Herceptin
Drug: Cisplatin

Regimen A: Cisplatin IV over 2 hours on day 1 following gemcitabine.

Regimen B: Cisplatin IV over 2 hours on day 1.

Other Names:
  • Platinol
  • Platinol-AQ
  • CDDP
Drug: Gemcitabine Hydrochloride

Regimen A: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.

Regimen B: Gemcitabine IV over 30 minutes on day 1. Gemcitabine IV over 30 minutes on day 8 following Trastuzumab.

Other Names:
  • Gemzar
  • Gemcitabine

Detailed Description:

OBJECTIVES: I. Determine the therapeutic efficacy and toxicity of cisplatin, gemcitabine, and trastuzumab (Herceptin) in patients with untreated p185-HER2 overexpressing stage IIIB or IV non-small cell lung cancer. II. Determine the pharmacokinetic interactions among these drugs in these patients. III. Assess the pharmacodynamics of these drugs in these patients.

OUTLINE: This is a multicenter study. Regimen A: Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab (Herceptin) IV over 90 minutes on day 2. Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15. Patients proceed to regimen B on day 22 of regimen A. Regimen B: Patients receive trastuzumab IV over 30-90 minutes, gemcitabine IV over 30 minutes, and cisplatin IV over 2 hours on day 1. Patients receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 30-90 minutes on day 15. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Maintenance: After completion of 6 courses, patients with stable disease or partial response receive trastuzumab IV over 30-90 minutes weekly until tumor progression.

PROJECTED ACCRUAL: A total of 20-48 patients 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: Immunohistochemically confirmed p185-HER2 expressing stage IIIB (pleural effusions only) or IV non-small cell lung cancer Confirmed overexpression at least: 1+ p185-HER2 (by DAKO Hercep Test) OR 15 ng/mL serum HER2/neu shed antigen (by Human HER2 Quantitative ELISA) At least 1 site of measurable disease outside of prior radiation port Brain metastases allowed provided clinical neurologic status is stable and head CT scan is stable to improved

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: More than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGPT no greater than 1.5 times normal Renal: Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months No unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmia Ejection fraction at least 40% Other: No other malignancy within the past 5 years No concurrent serious infection, including post-obstructive pneumonia No more than 10% weight loss in past 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy (including radiotherapy for brain metastases) No concurrent radiotherapy to only site of measurable disease Surgery: At least 2 weeks since prior major surgery No concurrent surgery on only site of measurable disease

  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: NCT00016367

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Roy S. Herbst, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00016367     History of Changes
Other Study ID Numbers: DM99-015, P30CA016672, MDA-DM-99015, NCI-4450, CDR0000068626
Study First Received: May 6, 2001
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Gemcitabine
Trastuzumab
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014