Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer, limited stage small cell lung cancer, recurrent small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.
Detailed description
OBJECTIVES: * Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin. * Determine the median survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed). Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Interventions
DRUGcarboplatin
Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
DRUGirinotecan
Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Sponsors
National Cancer Institute (NCI)
Pfizer
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria: * Previously untreated metastatic or extensive disease * Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease * Prior radiotherapy allowed * Recurrent disease * Limited, metastatic, or extensive disease * Relapsed after prior chemotherapy, excluding irinotecan hydrochloride * At least 90 days since prior chemotherapy * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by physical examination or radiographic techniques * Known brain metastases allowed PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * White Blood Cells \> 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Bilirubin ≤ 1.5 mg/dL * SGOT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No medical disease that, in the opinion of the investigator, would preclude study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 10 days since prior radiotherapy (including brain) * No prior irinotecan hydrochloride * At least 2 weeks since prior and no concurrent anticonvulsants * No concurrent radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to 36 months | Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Survival of Patients Treated With This Regimen | Up to 36 months | The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive. |
| Number of Participants With Toxicity | Up to 36 months | All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle. |
Countries
United States
Participant flow
Recruitment details
The recruitment period was 6 years. Subjects were recruited at 4 large medical centers.
Participants by arm
| Arm | Count |
|---|---|
| Arm A Metastatic small cell lung cancer with no previous chemotherapy | 40 |
| Arm B Relapsed small cell lung cancer with previous chemotherapy | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Arm A | Arm B | Total |
|---|---|---|---|
| Age, Continuous | 67 years | 65 years | 65 years |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 18 Participants | 23 Participants | 41 Participants |
| Sex: Female, Male Male | 22 Participants | 17 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 40 | 40 / 40 |
| serious Total, serious adverse events | 2 / 40 | 2 / 40 |
Outcome results
Primary
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Up to 36 months
Population: All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A | Overall Response Rate | 65 percentage of participants |
| Arm B | Overall Response Rate | 50 percentage of participants |
Secondary
Median Survival of Patients Treated With This Regimen
The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.
Time frame: Up to 36 months
Population: All participants for whom response evaluation measurements were recorded at Baseline and after 2 cycles.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A | Median Survival of Patients Treated With This Regimen | 10 months |
| Arm B | Median Survival of Patients Treated With This Regimen | 10 months |
Secondary
Number of Participants With Toxicity
All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.
Time frame: Up to 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A | Number of Participants With Toxicity | 40 Participants |
| Arm B | Number of Participants With Toxicity | 40 Participants |