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

Lung Cancer Clinical Trial

Official title:

Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00356941
• Other study ID #: 2005LS073
• Secondary ID: UMN-0511M77529UM
• Status: Terminated
• Phase: Phase 1
• First received: July 26, 2006
• Last updated: November 27, 2017
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: November 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• docetaxel
60 mg/m2 on day 1 of each week during radiation therapy
• oxaliplatin
Escalating dose per assignment: 20-50 mg/m2 on day 2 of each week during radiation therapy

Procedure:
• radiation therapy
2 Gy Days 1-5 each week, total dose of 70Gy

Locations

Country	Name	City	State
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy		Within 90 days of radiotherapy
Secondary	Dose-limiting toxicities		Within 90 days of radiotherapy
Secondary	Objective tumor response		Every 3 months up to 24 months