Lung Cancer, Non-Small-Cell Lung Carcinoma
Conditions
Keywords
Previously Untreated, Advanced
Brief summary
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Detailed description
Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition. Docetaxel is also approved for second line treatment of metastatic NSCLC. Research indicates that capecitabine, in combination with docetaxel, has efficacy against NSCLC. Capecitabine appears to have anti-cancer activity through several enzymes. This drug is metabolized in the body to another agent called 5-FU. During this conversion process, 5-FU requires thymidine phosphorylase (TP), a cellular characteristic associated with tumor growth. There are higher levels of TP expression in tumors as compared to normal tissue. The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine. This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC. Purpose: This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC. Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies. Treatment: Patients in this study will receive docetaxel and capecitabine. Docetaxel will be administered through intravenous infusions. Capecitabine will be provided through oral pills. A four-week period constitutes one cycle. Docetaxel will be given weekly for three weeks followed by one week of rest. Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Interventions
DRUGCapecitabine
1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
DRUGDocetaxel
36 mg/m2 IV weekly for 3 weeks every 4 weeks.
Sponsors
Roche Pharma AG
Tony Bekaii-Saab
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
* Must have advanced NSCLC * No prior chemotherapy * Eastern Cooperative Oncology Group(ECOG)Performance Status:0 or 1 * Must have measurable disease (RECIST criteria) * life expectancy of at least 12 weeks * adequate organ function including
Exclusion criteria
* Pregnant or lactating women * Psychiatric disorders that would interfere w/consent or follow-up * Patients with uncontrolled diabetes mellitus, defined as random blood sugar \> 250mg/dL.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine Objective Response Rate | Every 35 days | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 |
|---|---|
| Time to Tumor Progression | Every 35 days |
| One Year Survival | one year |
| Pharmacokinetics | Cycle 2 |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled and received treatment between December 2004 and November 2007
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel and Capecitabine Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.
Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Docetaxel and Capecitabine |
|---|---|
| Age, Continuous | 61 years |
| ECOG (Eastern Cooperative Oncology Group) Performance status 0 (Fully active) | 8 patients |
| ECOG (Eastern Cooperative Oncology Group) Performance status 1 (Restricted activity) | 21 patients |
| Histology Adenocarcinoma | 13 patients |
| Histology Large cell Carcinoma | 2 patients |
| Histology NSCLC not specified | 8 patients |
| Histology Squamous cell carcinoma | 6 patients |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 29 patients |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
Primary
Determine Objective Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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: Every 35 days
Population: One patient was not evaluable for response because the patient was removed from study afer an adverse event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Docetaxel and Capecitabine | Determine Objective Response Rate | Complete response (CR) | 0 patients |
| Docetaxel and Capecitabine | Determine Objective Response Rate | Partial response (PR) | 5 patients |
| Docetaxel and Capecitabine | Determine Objective Response Rate | Stable Disease | 14 patients |
| Docetaxel and Capecitabine | Determine Objective Response Rate | Disease Progression | 9 patients |
| Docetaxel and Capecitabine | Determine Objective Response Rate | Overall response (CR + PR) | 5 patients |
Secondary
One Year Survival
Time frame: one year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Docetaxel and Capecitabine | One Year Survival | 10.5 months |
Secondary
Pharmacokinetics
Time frame: Cycle 2
Population: No Pharmacokinetics were conducted for this trial.
Secondary
Time to Tumor Progression
Time frame: Every 35 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Docetaxel and Capecitabine | Time to Tumor Progression | 3.3 months |