Combination Chemotherapy as Induction Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Phase I/II Trial of the Combination of Docetaxel, Gemcitabine and Cisplatin (DGP) as Induction Chemotherapy in Patients With Stage III 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy with docetaxel, gemcitabine, and cisplatin as induction therapy in treating patients with stage III non-small cell lung cancer.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: cisplatin; Drug: gemcitabine hydrochloride

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and schedule of docetaxel, gemcitabine, and cisplatin as induction chemotherapy in patients with Stage III non-small cell lung cancer (NSCLC) scheduled to undergo subsequent surgical resection or irradiation. II. Determine the major objective response rate of this combination therapy in these patients.

OUTLINE: This is a dose escalation study. Docetaxel in administered as a 1 hour IV infusion at week 1, 5, and 9. Gemcitabine is administered as a 30 minute IV infusion at weeks 1, 2, 3, 5, 6, 7, 9, 10, and 11. Cisplatin is administered as a 20 minute IV infusion at weeks 3, 7, and 11. In addition, G-CSF is administered subcutaneously on days 2 through 6 of each 28 day cycle following each dose of docetaxel. Three patients are entered at each dose level and must complete one cycle of therapy. If no patient experiences dose limiting toxicity (DLT), then 3 patients are treated at the next higher dose level. If 1 patient experiences DLT, then 3 more patients are treated at that same dose level. If 2 of 6 patients experience DLT, then that dose is declared the maximum tolerated dose (MTD). Once the MTD is determined, the Phase II portion of the study begins and additional patients are treated at the dose level just below the MTD. Patients who show complete or partial response, or no change, after chemotherapy, undergo surgical resection or radiotherapy to remove or reduce their tumor. Patients are assessed for disease progression and unacceptable toxicities every 4 weeks till end of treatment.

PROJECTED ACCRUAL: An estimated 40 patients will be accrued in this study.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

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: Histologically confirmed Stage III (T1-2 N2-3 M0, T3 N2 M0, or T4 N0-3 M0) non-small cell lung cancer Must be candidates for either a resection with curative intent or definitive thoracic irradiation following induction chemotherapy No malignant pericardial or pleural effusions or superior vena cava syndrome Must have measurable or evaluable indicator lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 160,000/mm3 Hepatic: Bilirubin no greater than 1.0 mg/dL SGOT and/or SGPT no greater than 1.5 times the upper limit of normal Alkaline phosphatase no greater than 5 times the upper limit of normal Renal: Creatinine clearance at least 65 mL/min Cardiovascular: Must have stable heart rhythm No unstable angina No myocardial infarction within 6 months No clinical evidence of congestive heart failure Neurologic: Must have normal auditory function No symptoms of peripheral neuropathy Other: No prior malignancy except non-melanoma skin cancer or in situ carcinoma of the cervix Not pregnant Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy Surgery: Not specified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Jorge Gomez, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 1997
• Primary Completion (Actual): March 1, 2002
• Study Completion (Actual): March 1, 2002

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: November 24, 2003
• First Posted (Estimate): November 25, 2003

Study Record Updates

• Last Update Posted (Estimate): June 27, 2013
• Last Update Submitted That Met QC Criteria: June 25, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gemcitabine; Docetaxel; Cisplatin
• Other Study ID Numbers: 97-040; CDR0000065659 (Registry Identifier: PDQ (Physician Data Query)); NCI-G97-1285