Bronchioloalveolar Cell Variant of Non-small Cell Lung Cancer
Conditions
Keywords
non small cell lung cancer
Brief summary
The primary objective of this study is to determine the major objective response rate of OSI-774 in participants with unresectable or metastatic bronchioloalveolar cell variant of non-small cell lung cancer. This study is a Phase II study. The first study of OSI-774 was done to evaluate what dose should be given to patients with cancer has been completed. The purpose of this research study is to see whether this experimental treatment, called OSI-774, can cause a type of non-small cell lung cancer to stop growing or shrink. This study is sponsored by a company called Genentech, and is being done at Memorial Hospital, as well as other cancer centers around the country interested in developing new drugs for the treatment of this type of cancer.
Interventions
DRUGOSI-774: erlotinib, TarcevaTM
150 mg, 100 mg and 25 mg tablets
Sponsors
M.D. Anderson Cancer Center
Northwestern University
Vanderbilt-Ingram Cancer Center
Dana-Farber Cancer Institute
Genentech, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Either bronchioloalveolar cell carcinoma or a variant thereof after review * Clinical stage IIIB (malignant pleural or pericardial effusion) or IV or recurrent/medically inoperable disease * Measurable or evaluable indicator lesions * No prior or one chemotherapy regimen for NSCLC * Three weeks since last chemotherapy, and three weeks since prior radiation therapy to a major bone-marrow containing area * Karnofsky performance status \> or = to 80% OR ECOG performance status ≤ or = to 1 * Life expectancy \> or = to 8 weeks * Adequate hematologic, renal and/or hepatic function: WBC \> or = to 3,000/ul, hemoglobin \> or = to 9.0 g/dl, platelet count \> or = to 100,000/ul, total bilirubin \< or = to 1.0 mg/dl, AST \< than or = to 2.5 X UNL, creatinine \< or = to 1.5 mg/dl or Clcr \> or = to 55ml/min. * Effective contraception
Exclusion criteria
* Prior exposure to OSI-774 or other treatments targeting the HER family axis (e.g.-trastuzumab, ZD1839, C225, etc.) * Two or more prior chemotherapy regimens * Concurrent active cancer * Uncontrolled central nervous system metastases (i.e. any known CNS lesion which is radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids) * Pregnant or lactating women * Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin * Prior systemic cytotoxic chemotherapy for other malignant disease * Significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure, recent MI, unstable angina, active infection, uncontrolled hypertension).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Objective Response of OSI-774 | 53 weeks | (complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 - OSI-774 OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | 1 - OSI-774 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 44 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 66 / 81 |
| serious Total, serious adverse events | 22 / 81 |
Outcome results
Primary
Overall Objective Response of OSI-774
(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.
Time frame: 53 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 - OSI-774 | Overall Objective Response of OSI-774 | Complete Response (CR) | 1 participants |
| 1 - OSI-774 | Overall Objective Response of OSI-774 | Partial Response (PR) | 18 participants |
| 1 - OSI-774 | Overall Objective Response of OSI-774 | Stable Disease (SD) | 31 participants |
| 1 - OSI-774 | Overall Objective Response of OSI-774 | Progression of Disease (POD) | 30 participants |