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

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

docetaxel

oxaliplatin

radiation therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemoradiation Treated Patients

Arm Description

Patients receiving Docetaxel, Oxaliplatin and radiotherapy.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy

Secondary Outcome Measures

Dose-limiting toxicities

Objective tumor response

Full Information

NCT ID

NCT00356941

First Posted

July 26, 2006

Last Updated

November 27, 2017

Sponsor

Masonic Cancer Center, University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT00356941

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Withdrawn due to lack of accrual

Study Start Date

April 2006 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemoradiation Treated Patients

Arm Type

Experimental

Arm Description

Patients receiving Docetaxel, Oxaliplatin and radiotherapy.

Intervention Type

Drug

Intervention Name(s)

docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

oxaliplatin

Other Intervention Name(s)

Eloxatin

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

radiation therapy

Other Intervention Name(s)

radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy

Time Frame

Within 90 days of radiotherapy

Secondary Outcome Measure Information:

Title

Dose-limiting toxicities

Time Frame

Within 90 days of radiotherapy

Title

Objective tumor response

Time Frame

Every 3 months up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

L. Chinsoo Cho, MD

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Study Chair

Facility Information:

Facility Name

University of Minnesota Cancer Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial