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

October 25, 2018 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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:
  • CDDP
  • Platinol
  • Platinol-AQ
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 Names:
  • 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:
  • CDDP
  • Platinol
  • Platinol-AQ
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
21 days cycles for 6 courses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Roy S. Herbst, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 1999

Primary Completion (Actual)

December 14, 2004

Study Completion (Actual)

December 14, 2004

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

February 26, 2004

First Posted (Estimate)

February 27, 2004

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM99-015
  • P30CA016672 (U.S. NIH Grant/Contract)
  • MDA-DM-99015 (Other Identifier: UT MD Anderson Cancer Center)
  • NCI-4450
  • CDR0000068626 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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