Neoplasms, Unknown Primary
Conditions
Keywords
Neoplasms, Unknown Primary
Brief summary
In this phase II trial, we will evaluate the feasibility and efficacy of the oxaliplatin/capecitabine combination in patients who have had one previous chemotherapy regimen for the treatment of carcinoma of unknown primary site. Patients who are relapsed after a previous response to treatment will be eligible, as well as those who were refractory to first-line therapy.
Detailed description
All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 PO BID was administered on days 1-14 of each cycle.
Interventions
DRUGOxaliplatin
130 mg/m2 IV day 1 of 21 day cycle
DRUGCapecitabine
1000 mg/m2 by mouth twice daily on days 1-14 of each 21 day cycle
Sponsors
Roche Pharma AG
Sanofi-Synthelabo
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 carcinoma of unknown primary site * Progressive disease after treatment with one previous chemotherapy regimen. * Treatment with one previous immunotherapy or biotherapy regimen. * No previous treatment with oxaliplatin, capecitabine, or 5-FU. * Previous treatment with other platinum agents * Patients must have measurable or evaluable disease * ECOG Performance Status more than 2 * Adequate bone marrow, liver and kidney function * 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: * Age \< 18 years * History of treatment of any invasive malignancy within the last 5 years * Coexistent medical illnesses * Clinically significant cardiac disease * Preexisting peripheral neuropathy \> grade 1 * Lack of physical integrity of the upper gastrointestinal tract * Pre-existing uncontrolled coagulopathy * Women who are pregnant or lactating Please note: There are additional inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 18 months | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 18 months | Length of time, in months, that patients were alive from their first date of protocol treatment until death. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age Continuous | 59 years |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 48 |
| serious Total, serious adverse events | 23 / 48 |
Outcome results
Primary
Progression Free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: 18 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Progression Free Survival | 3.7 months |
Secondary
Overall Survival
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Time frame: 18 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Overall Survival | 9.7 months |