Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC

NCT ID: NCT00356941

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-05-31

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .

Detailed Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or recurrent non-small cell lung cancer.

Secondary

• Determine the dose-limiting toxicities of this regimen in these patients.
• Determine the objective tumor response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of oxaliplatin.

• Induction therapy: Patients undergo radiotherapy once a day on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47. Patients also receive docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and oxaliplatin IV over 2-4 hours on days 2, 9, 16, 23, 30, 37, and 44. Patients with stable or responding disease proceed to consolidation therapy.

Cohorts of 6 patients receive escalating doses of oxaliplatin during induction therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

• Consolidation therapy: Beginning 3 weeks after the completion of induction therapy, patients receive consolidation therapy comprising docetaxel IV over 1 hour immediately followed by oxaliplatin IV over 2-4 hours on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months for up to 2 years.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemoradiation Treated Patients

Patients receiving Docetaxel, Oxaliplatin and radiotherapy.

Group Type: EXPERIMENTAL

docetaxel

Intervention Type: DRUG

60 mg/m2 on day 1 of each week during radiation therapy

oxaliplatin

Intervention Type: DRUG

Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy

radiation therapy

Intervention Type: PROCEDURE

2 Gy Days 1-5 each week, total dose of 70Gy

Interventions

docetaxel

60 mg/m2 on day 1 of each week during radiation therapy

Intervention Type: DRUG

oxaliplatin

Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy

Intervention Type: DRUG

radiation therapy

2 Gy Days 1-5 each week, total dose of 70Gy

Intervention Type: PROCEDURE

Other Intervention Names

Taxotere; Eloxatin; radiotherapy

Eligibility Criteria

Inclusion Criteria

• Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:

• Medically inoperable or unresectable stage II, IIIA, or IIIB disease
• Post-resection intrathoracic tumor recurrence
• Measurable disease by computed tomography(CT) scan
• No evidence of small cell histology
• No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology
• No metastatic disease
• Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
• Absolute granulocyte count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• Bilirubin ≤ 1.5 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) ≤ 1.5 times upper limit of normal (unless abnormality is caused by documented benign disease)
• Creatinine ≤ 1.5 mg/dL
• Weight loss ≤ 10% within the past 3 months
• Forced expiratory volume (FEV) 1 ≥ 1,000 cc
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

Exclusion Criteria

• Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for > 3 years
• Myocardial infarction within the past 6 months
• Symptomatic heart disease, including any of the following:

• Angina
• Congestive heart failure
• Uncontrolled arrhythmia
• Active infection or fever ≥ 38.5°C within the past 3 days
• Known hypersensitivity to any of the components of oxaliplatin or docetaxel
• Prior thoracic or neck radiotherapy
• Prior docetaxel or oxaliplatin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Masonic Cancer Center, University of Minnesota

Principal Investigators

L. Chinsoo Cho, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

UMN-0511M77529

Identifier Type: OTHER

Identifier Source: secondary_id

UMN-OX-04-007

Identifier Type: OTHER

Identifier Source: secondary_id

2005LS073

Identifier Type: -

Identifier Source: org_study_id