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NCT00032032

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

NCT ID: NCT00032032

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-05-31

Study Completion Date

2010-01-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.

Detailed Description

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OBJECTIVES:

* Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer.
* Determine the 2-year survival of patients treated with this regimen.
* Determine the progression-free local control rate in patients treated this regimen.
* Determine the tolerability of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.

Patients undergo radiotherapy\* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: \*No prophylactic nodal radiotherapy is administered

Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at that dose level in the phase II portion of the study.

Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years.

Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

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Lung Cancer

Keywords

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stage I 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

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiotherapy + paclitaxel + carboplatin

Patients undergo radiotherapy once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years.

Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Interventions

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carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

* Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons
* Measurable disease
* Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study
* No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions
* No more than small effusions seen on chest CT scan only
* No supraclavicular adenopathy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
* Direct bilirubin no greater than 1.5 times ULN
* AST no greater than 3 times ULN

Renal:

* Creatinine clearance at least 40 mL/min

Cardiovascular:

* No New York Heart Association class III or IV heart disease

Pulmonary:

* FEV\_1 at least 1 L or 35% of predicted

Other:

* No grade 2 or greater peripheral neuropathy
* No weight loss of 10% or more within the past 3 months
* No uncontrolled infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer
* No other severe underlying disease that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic:

* No prior biologic therapy for NSCLC
* No concurrent biologic therapy
* No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

* No prior chemotherapy for NSCLC
* No other concurrent chemotherapy

Endocrine therapy:

* No prior endocrine therapy for NSCLC

Radiotherapy:

* No prior radiotherapy for NSCLC

Surgery:

* No prior surgery for NSCLC

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven E. Schild, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status