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NCT00711243 · ClinicalTrials.gov registry record · Phase 1
Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor
A Phase 1 study of Gastric Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT00711243: Completed Phase 1 study of Gastric Cancer and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Northwestern University.
NCT00711243 is a Phase 1 study of Gastric Cancer and Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by Northwestern University. The registered enrollment target is 59 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00711243, a Phase 1 study of Gastric Cancer and Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.
Primary Outcome
The MTD will be determined using a 3+3 dose escalating design. There will be 5 dose cohorts: Cohort 1a 25mg/m2 Cohort 2a 30mg/m2 Cohort 3a 40 mg/m2 Cohort 4a 50 mg/m2 Cohort 5a 60 mg/m2 3 patients will be enrolled at dose of 25mg/m2 docetaxel. If no dose limiting toxicities (DLTs) are seen then dose will be escalated to next cohort and 3 patients will be treated at that dose level. If a DLT is seen at any dose, then 3 more patients will be enrolled at that dose level. If 1 patient out of 6, ex
Conditions Studied
Interventions
- DRUG docetaxel
- DRUG oxaliplatin
- DRUG fluorouracil
Study Locations (1)
Illinois
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2005-04-20 |
| Est. Completion | 2011-02-25 |
| Phase | Phase 1 |
What the finished NCT00711243 record still lists
NCT00711243 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 3 interventions - of which docetaxel is the first listed.
NCT00711243 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00711243 about?
NCT00711243 is a clinical study titled "Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor". RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: ...
What is the current status of trial NCT00711243?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2005-04-20. Estimated completion is 2011-02-25.
What conditions does trial NCT00711243 study?
This clinical trial studies the following conditions: Gastric Cancer, Unspecified Adult Solid Tumor, Protocol Specific.
What interventions are being tested in trial NCT00711243?
The interventions under investigation include: docetaxel (DRUG), oxaliplatin (DRUG), fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00711243?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00711243 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00711243's enrollment target sits among peer trials
59 111th of 153 higher than 43 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer 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.
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