Lung Cancer
Conditions
Brief summary
This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.
Detailed description
Upon determination of eligibility, patients will receive: Pre-operative * Docetaxel * Gemcitabine Post-operative * Docetaxel * Carboplatin * Radiation Therapy Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment
Interventions
DRUGDocetaxel
30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
DRUGGemcitabine
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
DRUGCarboplatin
AUC = 1.5 weekly x 7
RADIATIONRadiation
To 63 Gy
Sponsors
Aventis Pharmaceuticals
Eli Lilly and Company
SCRI Development Innovations, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study, you must meet the following criteria: * Histologically confirmed non-small cell lung cancer * Must be operable candidate * Clinical stage IB, II, and select III non-small cell lung cancer are eligible * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Must be \> 18 years of age * Adequate bone marrow, liver or kidney * No previous chemotherapy or radiation therapy for non-small cell lung cancer * Moderate to severe peripheral neuropathy * Understand the nature of this study and give written informed consent.
Exclusion criteria
You cannot participate in this study if any of the following apply to you: * Stage IV disease * History of prior malignancy within five years * Women who are pregnant or breast-feeding Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Rate | 18 months | A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 19 months | Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause. |
| Overall Response Rate (ORR) | 18 months | Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. |
| Overall Survival (OS) | 18 months | Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 62 years |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 75 / 75 |
| serious Total, serious adverse events | 39 / 75 |
Outcome results
Primary
Pathologic Complete Response Rate
A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.
Time frame: 18 months
Population: All patients who underwent a thoracotomy were assigned a pathologic response category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Pathologic Complete Response Rate | 0 Percentage of participants |
Secondary
Overall Response Rate (ORR)
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Time frame: 18 months
Population: Patients who were assessable after completion of 9 weeks of treatment were evaluated and assigned a response category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Overall Response Rate (ORR) | 30 percentage of participants |
Secondary
Overall Survival (OS)
Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.
Time frame: 18 months
Population: All patients were assessed for overall survival after a median follow-up of 19 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Overall Survival (OS) | 18 Months |
Secondary
Progression Free Survival (PFS)
Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.
Time frame: 19 months
Population: All patients were assessed for progression free survival after a median follow up of 19 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Progression Free Survival (PFS) | 9.9 Months |