Phase 2
N=48
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
Neoplasms, Unknown Primary
Bottom Line
View on ClinicalTrials.gov: NCT00193609 ↗Enrolled (actual)
48
Serious AEs
47.9%
Results posted
Oct 2013
Primary outcome: Primary: Progression Free Survival — 3.7 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxaliplatin (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
3.7 | — |
| SECONDARY Overall Survival |
9.7 | — |
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.
Eligibility Criteria
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 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/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Data sourced from ClinicalTrials.gov (NCT00193609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.