Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non small Cell Lung Cancer Stage IIIb and IV
Brief summary
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.
Detailed description
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive: * oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15 * docetaxel 30mg/m2 on Days 1 and 8 Cycles are to be repeated every 28 days for a maximum of 6 cycles.
Interventions
DRUGOxaliplatin + Docetaxel
Oxaliplatin 85mg/m2 Docetaxel 30mg.m2
Sponsors
Sanofi-Synthelabo
Oncology Specialists, S.C.
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
* Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) * Patients must have measurable disease * Age greater than or equal to 18 years * ECOG performance score of 0, 1, or 2 * Absolute neutrophil count (ANC) \> 1,500 * Platelets \> 100,000 * Serum creatinine \< 1.5mg/dL * Serum total bilirubin \< 1.5mg/dL * Alkaline phosphatase \< 3 times the upper limit of normal * SGOT/SGPT \< 3 times the upper limit of normal * Patients must be recovered from the effects of any prior surgery or RT. * Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial. * Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medications.
Exclusion criteria
* Patients with an active infection \> 38.5 degrees Celsius within 3 days of the first scheduled day of protocol treatment * Patients with active central nervous system (CNS) metastasis. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 2 weeks are eligible for the trial. * History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin; cervical intra-epithelial neoplasm, or localized prostate cancer with a current prostate specific antigen (PSA) of \< 1.0 mg/dL * Patients with known hypersensitivity to any of the components of oxaliplatin or docetaxel * Patients who have had prior chemotherapy for lung cancer * Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment * Grade 2 peripheral neuropathy * Patients who are pregnant or lactating * Any other medical condition, including mental illness or substance abuse deemed by the investigator to be likely to interfere with the patients' ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results * History of allogeneic transplant * Known HIV, hepatitis B or C (active, previously treated, or both)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Response is measured every 2 cycles until disease progression | Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | <1 cycle to 6 cycles of treatment | Progression is measured from each participants start of study until removal from treatment. |
| Duration of Response | 0 -12 months | Duration of response is a measure of how long the participants response to therapy was maintained. |
| Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | day one of cycle one until participant removed from trial | Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle. |
Countries
United States
Participant flow
Recruitment details
patients recruited from clinical practice.
Pre-assignment details
patients were screened to see if they met eligibility criteria. If criteria met, enrolled into study. Otherwise listed as screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Oxaliplatin + Docetaxel Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Oxaliplatin + Docetaxel |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 15 |
| serious Total, serious adverse events | 9 / 15 |
Outcome results
Primary
Response Rate
Response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC. Per RECIST 1.0 defines a complete response (CR)as the disappearance of all disease. A partial response(PR) as a minimum of a 30% decrease in the sum of the longest dimension of target lesions. Progressive disease (PR) is defined as a minimum of a 20% increase in the sum of the longest dimension of target lesions. Stable disease is defined as neither sufficient shrinkage to qualify as a PR nor sufficient increase to qualify as PD.
Time frame: Response is measured every 2 cycles until disease progression
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxaliplatin + Docetaxel | Response Rate | partial response | 7 Participants |
| Oxaliplatin + Docetaxel | Response Rate | complete response | 0 Participants |
| Oxaliplatin + Docetaxel | Response Rate | stable disease | 1 Participants |
Secondary
Duration of Response
Duration of response is a measure of how long the participants response to therapy was maintained.
Time frame: 0 -12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxaliplatin + Docetaxel | Duration of Response | 7.9 months |
Secondary
Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial.
Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V 3.0) and the incidence of any Grade 3 or 4 toxicities will be analyzed. Toxicity is assessed every cycle.
Time frame: day one of cycle one until participant removed from trial
Population: all participants had adverse events
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 anemia | 1 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | grade 3 or 4 thrombocytopenia | 1 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 fatigue | 5 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 dehydration | 2 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 nausea | 1 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 diarrhea | 2 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 anorexia | 1 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 neutropenia | 3 participants |
| Oxaliplatin + Docetaxel | Safety Objective is to Describe the Safety Profile of 1st Line Treatment by Recording Grade 3 and 4 Adverse Events Experienced by Participants in This Trial. | Grade 3 or 4 vomiting | 2 participants |
Secondary
Time to Progression
Progression is measured from each participants start of study until removal from treatment.
Time frame: <1 cycle to 6 cycles of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oxaliplatin + Docetaxel | Time to Progression | 2.4 months |