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NCT00062062

Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

NCT ID: NCT00062062

Last Updated: 2016-12-14

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

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2010-11-30

Brief Summary

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RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.

Detailed Description

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OBJECTIVES:

Primary

* Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel.

Secondary

* Determine the response rate in patients treated with these regimens.
* Determine the quality of life of patients treated with these regimens.
* Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens.
* Correlate the presence of social support for these patients with toxicity and efficacy of these regimens.
* Determine whether social support for these patients differs according to gender.
* Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients.

Tertiary

* Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician.

* Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.

Conditions

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Lung Cancer

Keywords

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stage IV non-small cell lung cancer stage IIIB non-small cell lung cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gefitinib

Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

Group Type EXPERIMENTAL

gefitinib

Intervention Type DRUG

paclitaxel + carboplatin + gefitinib

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I.

Quality of life is assessed at baseline and after the completion of course 2.

Patients are followed every 3 months for 5 years.

Group Type EXPERIMENTAL

carboplatin

Intervention Type DRUG

gefitinib

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Interventions

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carboplatin

Intervention Type DRUG

gefitinib

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

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

* Metastatic or unresectable disease
* Measurable disease

* At least 1 lesion at least 2.0 cm
* Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy
* No meningeal carcinomatosis
* No untreated brain metastases

* Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy
* No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy)

PATIENT CHARACTERISTICS:

Age

* 65 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 12 weeks

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL

Hepatic

* Bilirubin no greater than 2.0 mg/dL
* No uncontrolled hepatic disease

Renal

* Creatinine no greater than 2 times upper limit of normal
* No uncontrolled renal disease

Cardiovascular

* No uncontrolled cardiac disease

Pulmonary

* No clinically active interstitial lung disease

* Asymptomatic, chronic stable radiographic changes allowed
* No uncontrolled respiratory disease

Other

* Fertile patients must use effective contraception
* Able and willing to complete questionnaires alone or with assistance
* No known hypersensitivity to gefitinib or any of its excipients
* No active infection within the past 2 weeks
* No other prior malignancy within the past 5 years except basal cell skin cancer
* No grade 2 or greater peripheral neuropathy (CTC v2.0)
* No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)
* No dysphagia or inability to swallow intact capsules
* No significant medical condition that would preclude study treatment or follow-up
* No severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics
* No prior chemotherapy for metastatic NSCLC

Endocrine therapy

* Concurrent steroids allowed provided the dose is not changed

Radiotherapy

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of marrow-containing skeleton
* No concurrent radiotherapy (including palliative)

Surgery

* See Disease Characteristics
* At least 3 weeks since prior major surgery
* No surgery within 7 days after study participation

Other

* More than 30 days since prior non-FDA approved investigational drugs
* No concurrent oral retinoids
* No concurrent CYP3A4-inducing agents, including the following:

* Carbamazepine
* Oxcarbazepine
* Modafinil
* Ethosuximide
* Griseofulvin
* Nafcillin
* Phenobarbital
* Phenylbutazone
* Phenytoin
* Primidone
* Rifampin
* Hypericum perforatum (St. John's wort)
* Barbiturates
* Sulfinpyrazone
* No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)
* No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration
* No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin

Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aminah Jatoi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

St. Anthony's Memorial Hospital

Effingham, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Kewanee Hospital

Kewanee, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

St. Luke's Hospital

Cedar Rapids, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status