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Phase II Randomized Study of Erlotinib With or Without Carboplatin and Paclitaxel in Patients With Chemotherapy-Naïve Select Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Erlotinib With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Active | 18 and over | CALGB-30406 NCT00126581 |
Special Category:
NCI Web site featured trial Objectives Primary - Determine the progression-free survival of patients with chemotherapy-naïve select stage IIIB or stage IV non-small cell lung cancer treated with erlotinib with or without carboplatin and paclitaxel.
Secondary - Determine the radiographic response rate in patients treated with these regimens.
- Correlate the frequency of epidermal growth factor receptor (EGFR) mutations and K-ras mutations with the response rate and time to progression in patients treated with these regimens.
- Determine the median and overall survival of patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed primary non-small cell lung cancer (NSCLC)
- Adenocarcinoma histology, including any of the following histologic variants:
- Pure or mixed bronchoalveolar cell carcinoma
- Adenosquamous cell carcinoma
- No NSCLC not otherwise specified
- Pathology block or unstained slides from initial or subsequent diagnosis available
- At least a core biopsy required
- Fine needle aspirate alone is not sufficient
- Meets 1 of the following stage criteria:
- Select stage IIIB disease with cytologically documented malignant pleural or pericardial effusion
- Stage IV disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- The following are considered non-measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Meets 1 of the following criteria for smoking history:
- Non-smoker, defined as a person who smoked ≤ 100 cigarettes in their lifetime
- Former light smoker, defined as a person who smoked ≤ 10 pack years AND quit smoking ≥ 1 year ago
- No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requires corticosteroids)
Prior/Concurrent Therapy:
Biologic therapy - No prior trastuzumab (Herceptin®) or cetuximab
Chemotherapy - No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
- No other concurrent chemotherapy
Endocrine therapy - See Disease Characteristics
- No concurrent hormonal therapy except for the following:
- Hormones for non-disease-related conditions (e.g., insulin for diabetes)
- Steroids for adrenal failure
- Intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel hypersensitivity reactions
Radiotherapy - At least 3 weeks since prior radiotherapy, including cranial irradiation
- No concurrent radiotherapy, including palliative radiotherapy
Surgery - At least 3 weeks since prior major surgery
- No prior significant surgical resection of the stomach or small bowel
Other - No prior erlotinib, gefitinib, or lapatinib
- No other prior treatment targeting the HER family axis
- More than 4 weeks since prior and no other concurrent investigational agents
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Granulocyte count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL
Hepatic - AST ≤ 2.5 times upper limit of normal (ULN)
- Total bilirubin ≤ ULN
Renal Gastrointestinal - Able to swallow tablets intact or dissolved in water
- No dysphagia
- No active gastrointestinal disease or disorder that would alter gastrointestinal motility or absorption
- No lack of integrity of the gastrointestinal tract
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment 180A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years. Outcomes Primary Outcome(s)Progression-free survival (PFS) rate at 18 weeks
Secondary Outcome(s)Response rate
Median and overall survival rate
Correlation of response with presence or absence of epidermal growth factor receptor (EGFR) mutations
PFS in presence or absence of EGFR mutations
Correlation of response and PFS in presence or absence of K-ras mutations
Toxicity
Outline This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.
Trial Contact Information
Trial Lead Organizations Cancer and Leukemia Group B  |  |  | | Pasi Janne, MD, PhD, Protocol chair |  | |  | | Vincent Miller, MD, Protocol co-chair |  | |  | Trial Sites
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| U.S.A. |
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| California |
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La Jolla |
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| | | | | | | | | Rebecca and John Moores UCSD Cancer Center |
| | | Clinical Trials Office - Rebecca and John Moores UCSD Cancer Center | |
| | Email:
cancercto@ucsd.edu |
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San Diego |
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| | | Kaiser Permanente Medical Office -Vandever Medical Office |
| | | Han Koh | |
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| Florida |
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Fort Lauderdale |
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| | | | Michael and Dianne Bienes Comprehensive Cancer Center
at Holy Cross Hospital |
| | | Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center | |
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Jupiter |
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| | | Ella Milbank Foshay Cancer Center at Jupiter Medical Center |
| | | Clinical Trials Office - Ella Milbank Foshay Cancer Center | |
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Miami Beach |
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| | | CCOP - Mount Sinai Medical Center |
| | | Rogerio Lilenbaum, MD | |
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| Georgia |
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Savannah |
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| | | | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center |
| | | Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute | |
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| Illinois |
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Chicago |
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| | | | University of Chicago Cancer Research Center |
| | | Clinical Trials Office - University of Chicago Cancer Research Center | |
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| Indiana |
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Elkhart |
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| | | | Elkhart General Hospital |
| | | Rafat Ansari, MD, FACP | |
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Kokomo |
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| | | Howard Community Hospital |
| | | Rafat Ansari, MD, FACP | |
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La Porte |
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| | | Center for Cancer Therapy at LaPorte Hospital and Health Services |
| | | Rafat Ansari, MD, FACP | |
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South Bend |
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| | | CCOP - Northern Indiana CR Consortium |
| | | Rafat Ansari, MD, FACP | |
| | | Memorial Hospital of South Bend |
| | | Clinical Trials Office - Memorial Hospital of South Bend | |
| | | Saint Joseph Regional Medical Center |
| | | Rafat Ansari, MD, FACP | |
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| Iowa |
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Iowa City |
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| | | | Holden Comprehensive Cancer Center at University of Iowa |
| | | Cancer Information Service | |
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| Maryland |
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Baltimore |
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| | | | Greenebaum Cancer Center at University of Maryland Medical Center |
| | | Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center | |
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| Massachusetts |
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Boston |
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| | | | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| | | Pasi Janne, MD, PhD | |
| | | Massachusetts General Hospital |
| | | Clinical Trials Office - Massachusetts General Hospital | |
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| Michigan |
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St. Joseph |
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| | | | Lakeland Regional Cancer Care Center - St. Joseph |
| | | Rafat Ansari, MD, FACP | |
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| Missouri |
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Columbia |
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| | | | Ellis Fischel Cancer Center at University of Missouri - Columbia |
| | | Clinical Trial Office - Ellis Fischel Cancer Center | |
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Saint Louis |
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| | | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
| | | Ramaswamy Govindan, MD | |
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| Nebraska |
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Grand Island |
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| | | | Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center |
| | | Margaret Kessinger, MD | |
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North Platte |
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| | | Callahan Cancer Center at Great Plains Regional Medical Center |
| | | Clinical Trials Office - Callahan Cancer Center at Great Plains Regional Medical Center | |
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Omaha |
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| | | UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
| | | Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
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| Nevada |
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Las Vegas |
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| | | | CCOP - Nevada Cancer Research Foundation |
| | | John Ellerton, MD, CM | |
| | | University Medical Center of Southern Nevada |
| | | John Ellerton, MD, CM | |
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| New York |
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East Syracuse |
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| | | | CCOP - Hematology-Oncology Associates of Central New York |
| | | Jeffrey Kirshner, MD | |
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New York |
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| | | Memorial Sloan-Kettering Cancer Center |
| | | Vincent Miller, MD | |
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Syracuse |
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| | | SUNY Upstate Medical University Hospital |
| | | Clinical Trials Office - SUNY Upstate Medical University Hospital | |
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| North Carolina |
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Chapel Hill |
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| | | | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill |
| | | Clinical Trials Office - Lineberger Comprehensive Cancer Center | | Ph: | 877-668-0683; 919-966-4432 | | |
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Charlotte |
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| | | Presbyterian Cancer Center at Presbyterian Hospital |
| | | Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital | |
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Durham |
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| | | Duke Comprehensive Cancer Center |
| | | Clinical Trials Office - Duke Comprehensive Cancer Center | |
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Goldsboro |
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| | | Wayne Memorial Hospital, Incorporated |
| | | James Atkins, MD | |
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Hendersonville |
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| | | Pardee Memorial Hospital |
| | | James Radford, MD | |
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Kinston |
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| | | Kinston Medical Specialists |
| | | Peter Watson, MD | |
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| Ohio |
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Columbus |
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| | | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | | Ohio State University Cancer Clinical Trial Matching Service | |
| | Email:
osu@emergingmed.com |
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| Oklahoma |
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Oklahoma City |
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| | | | Cancer Care Associates - Mercy Campus |
| | | Howard Ozer, MD, PhD | |
| | | Oklahoma University Cancer Institute |
| | | Howard Ozer, MD, PhD | |
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| Rhode Island |
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Pawtucket |
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| | | | Memorial Hospital of Rhode Island |
| | | Humera Khurshid | |
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| South Carolina |
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Florence |
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| | | | McLeod Regional Medical Center |
| | | Clinical Trials Office - McLeod Regional Medical Center | |
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Greenville |
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| | | CCOP - Greenville |
| | | Jeffrey Giguere, MD, FACP | |
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| Vermont |
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Berlin |
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| | | | Mountainview Medical |
| | | Dennis Sanders | |
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Burlington |
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| | | Fletcher Allen Health Care - University Health Center Campus |
| | | Clinical Trials Office - Fletcher Allen Health Care | |
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| Virginia |
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Richmond |
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| | | | Virginia Commonwealth University Massey Cancer Center |
| | | Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center | |
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Related Information Featured trial article
| Registry Information |  | | Official Title | | A Phase II Randomized Study of OSI-774 (ERLOTINIB) (NSC #718781; IND#63, 383) With or Without Carboplatin/Paclitaxel in Patients with Previously Untreated Adenocarcinoma of the Lung who Never Smoked or were Former Light Smokers |  | | Trial Start Date | | 2005-08-18 |  | | Trial Completion Date | | 2008-02-04 (estimated) |  | | Registered in ClinicalTrials.gov | | NCT00126581 |  | | Date Submitted to PDQ | | 2005-06-10 |  | | Information Last Verified | | 2009-06-27 |  | | NCI Grant/Contract Number | | CA31946 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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