Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving carboplatin together with docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving carboplatin together with docetaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
Detailed description
OBJECTIVES: Primary * Evaluate the feasibility of adjuvant carboplatin and docetaxel in patients with resected stage I, II, or IIIA non-small cell lung cancer. Secondary * Determine the toxicity of this regimen in these patients. * Determine the survival patterns of patients treated with this regimen. * Assess the patterns of recurrence in patients treated with this regimen. OUTLINE: Patients receive carboplatin IV on day 1 and docetaxel IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Interventions
DRUGcarboplatin
Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
DRUGdocetaxel
75 mg/m² intravenously, once, every 3 weeks
Sponsors
Aventis Pharmaceuticals
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed non-small cell lung cancer * Stage I-IIIA disease * Must have undergone a complete resection * Must begin adjuvant chemotherapy within 8 weeks of surgical resection PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Serum creatinine normal OR creatinine clearance ≥ 40 mL/min * Bilirubin normal * Alkaline phosphatase (AP), Aspartate aminotransferase (AST), and Alanine transaminase (ALT) must meet 1 of the following criteria: * AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study therapy
Exclusion criteria
* Patients with a history of severe hypersensitivity to docetaxel or polysorbate 80 are excluded. * Women who are currently or planning to breast feed. * Those with peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: * 2-8 weeks since prior surgery and recovered
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen | 12 weeks from initiating adjuvant therapy | Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns of Recurrence in Patients Treated With This Regimen | Up to 5 years | Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence. |
| Toxicity in Patients Treated With This Regimen | Day 1 of treatment to 30 days after treatment discontinuation | Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). |
| Progression Free Survival | The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months | Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence. |
| Overall Survival | The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months | Overall survival rate at 18 months. |
Countries
United States
Participant flow
Pre-assignment details
Of the 75 participants screened for eligibility, 72 went on to treatment and 3 participants withdrew consent prior to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Trial adjuvant carboplatin plus docetaxel carboplatin area under curve (AUC) = 6 IV on day 1 every 3 weeks for 4 cycles docetaxel 75 mg/m² IV on day 1 every 3 weeks for 4 cycles
carboplatin: Carboplatin will be given intravenously,once,every 3 weeks. The carboplatin area under curve (AUC) dose will be calculated using the Calvert Equation 19 as follows: Carboplatin dose (mg) = 6x (GFR + 25)
docetaxel: 75 mg/m² intravenously, once, every 3 weeks | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Intercurrent Illness | 2 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Single Arm Trial |
|---|---|
| Age, Continuous | 65 years |
| Eastern Cooperative Oncology Group (ECOG) Performance status 0 | 28 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance status 1 | 43 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance status 2 | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Histology Adenocarcinoma | 32 Participants |
| Histology Large cell carcinoma | 3 Participants |
| Histology Non-small cell-not otherwise specified | 7 Participants |
| Histology Squamous cell carcinoma | 30 Participants |
| Race/Ethnicity, Customized Ethnicity African American | 7 Participants |
| Race/Ethnicity, Customized Ethnicity Asian | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Latino | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown or Not Reported | 2 Participants |
| Race/Ethnicity, Customized Ethnicity White | 60 Participants |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 24 Participants |
| Stage Stage I | 29 Participants |
| Stage Stage II | 26 Participants |
| Stage Stage IIIA | 16 Participants |
| Stage Stage IIIB | 1 Participants |
| Type of surgery Bi-lobectomy | 7 Participants |
| Type of surgery Lobectomy | 52 Participants |
| Type of surgery Pneumonectomy | 11 Participants |
| Type of surgery Wedge resection | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 72 |
| serious Total, serious adverse events | 19 / 72 |
Outcome results
Primary
Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen
Feasibility was based on the percentage of patients completing four cycles of the carboplatin/docetaxel regimen to a high fraction of patients with curatively resected stage IIIIA non-small cell lung cancer within 12 weeks.
Time frame: 12 weeks from initiating adjuvant therapy
Population: Patients assigned to treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm Trial | Number of Participants Who Completed Four Cycles of the Carboplatin/Docetaxel Regimen | 57 Participants |
Secondary
Overall Survival
Overall survival rate at 18 months.
Time frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
Population: Participants receiving treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm Trial | Overall Survival | 86 percentage of participants |
Secondary
Patterns of Recurrence in Patients Treated With This Regimen
Patterns were assessed with a staging chest computerized tomography (CT), bone or positron emission tomography (PET) scan and brain magnetic resonance imaging (MRI)/CT scan at recurrence.
Time frame: Up to 5 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm Trial | Patterns of Recurrence in Patients Treated With This Regimen | intrathoracic relapse | 4 Participants |
| Single Arm Trial | Patterns of Recurrence in Patients Treated With This Regimen | intrathoracic and distant relapse | 5 Participants |
| Single Arm Trial | Patterns of Recurrence in Patients Treated With This Regimen | distant relapse only without brain | 2 Participants |
| Single Arm Trial | Patterns of Recurrence in Patients Treated With This Regimen | distant relapse within the brain | 8 Participants |
Secondary
Progression Free Survival
Relapse-free survival rate at 18 months. Patients were determined to have progression either by radiographic and/or pathological assessment by local physician per local standard of care monitoring for disease recurrence.
Time frame: The time between the start of treatment to disease progression or death or the date of last contact, measured up to 18 months
Population: Participants receiving treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm Trial | Progression Free Survival | 86 percentage of participants |
Secondary
Toxicity in Patients Treated With This Regimen
Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0).
Time frame: Day 1 of treatment to 30 days after treatment discontinuation
Population: Patients receiving treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Arrythmia | 0 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Diarrhea | 3 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Febrile Neutorpenia | 3 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Syncope | 5.5 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Infusional reactions | 4 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Thrombocytopenia | 1 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Fatigue/asthenia | 5.5 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Dehydration | 1 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Proteinuria | 0 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Nausea | 1 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Dyspnea | 0 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Neutropenia | 24 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Vomiting | 1 percentage of participants |
| Single Arm Trial | Toxicity in Patients Treated With This Regimen | Infection | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Arrythmia | 1 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Neutropenia | 42 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Thrombocytopenia | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Febrile Neutorpenia | 8 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Nausea | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Vomiting | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Diarrhea | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Infusional reactions | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Dehydration | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Fatigue/asthenia | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Syncope | 0 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Proteinuria | 1 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Infection | 3 percentage of participants |
| Grade 4 % | Toxicity in Patients Treated With This Regimen | Dyspnea | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Infection | 3 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Syncope | 5.5 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Vomiting | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Nausea | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Arrythmia | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Febrile Neutorpenia | 11 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Neutropenia | 65 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Proteinuria | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Thrombocytopenia | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Dehydration | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Infusional reactions | 4 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Dyspnea | 1 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Fatigue/asthenia | 5.5 percentage of participants |
| Grade 3/4 % | Toxicity in Patients Treated With This Regimen | Diarrhea | 3 percentage of participants |