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NCT00193609 · ClinicalTrials.gov registry record · Phase 2
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
A Phase 2 study of Neoplasms, Unknown Primary, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 10
- Study locations
NCT00193609: Completed Phase 2 study of Neoplasms, Unknown Primary, sponsored by SCRI Development Innovations.
NCT00193609 is a Phase 2 study of Neoplasms, Unknown Primary that has completed, run by SCRI Development Innovations. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00193609, a Phase 2 study of Neoplasms, Unknown Primary, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
Study Locations (10)
Kentucky
- Greenview Regional Hospital - Bowling Green
- Consultants in Blood Disorders and Cancer - Louisville
Tennessee
- Chattanooga Oncology Hematology Associates - Chattanooga
- Tennessee Oncology, PLLC - Nashville
Florida
- Integrated Community Oncology Network - Jacksonville
Indiana
- AP&S Oncology & Hematology Northside - Terre Haute
Louisiana
- Baton Rouge General Medical Center - Baton Rouge
Ohio
- Oncology Hematology Care - Cincinnati
Pennsylvania
- Reading Hospital Regional Cancer Center - West Reading
South Carolina
- Spartanburg Regional Medical Center - Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00193609 record still lists
NCT00193609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Neoplasms, Unknown Primary appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.
NCT00193609 lists 10 locations in 8 states (Kentucky, Tennessee, Florida).
Frequently Asked Questions
What is clinical trial NCT00193609 about?
NCT00193609 is a clinical study titled "Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site". 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 b...
What is the current status of trial NCT00193609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2004-09. Estimated completion is 2009-01.
What conditions does trial NCT00193609 study?
This clinical trial studies the following conditions: Neoplasms, Unknown Primary.
What interventions are being tested in trial NCT00193609?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00193609?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00193609 being conducted?
This trial has 10 study locations across Florida, Indiana, Kentucky, Louisiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms, Unknown Primary
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00193609's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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