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NCT01637194 · ClinicalTrials.gov registry record · Phase 1
Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer
A Phase 1 study of Recurrent Colon Cancer and Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT01637194: Completed Phase 1 study of Recurrent Colon Cancer and Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, sponsored by Fox Chase Cancer Center.
NCT01637194 is a Phase 1 study of Recurrent Colon Cancer and Recurrent Adenoid Cystic Carcinoma of the Oral Cavity that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 12 participants, below the 30-participant average among 10 other Recurrent Colon Cancer trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01637194, a Phase 1 study of Recurrent Colon Cancer and Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer
Primary Outcome
Dose-limiting toxicity defined as any grade 3 or greater non-hematologic, grade 4 thrombocytopenia, grade 4 neutropenia lasting more than 5 days, grade 4 febrile neutropenia requiring hospitalization or treatment delay more than 2 weeks due to unresolved toxicity.
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL cetuximab
- OTHER pharmacological study
- DRUG everolimus
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01637194 record still lists
NCT01637194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 30-participant average among 10 other Recurrent Colon Cancer trials with a reported enrollment target (60% lower).
The record links to 10 conditions, with Recurrent Colon Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01637194 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01637194 about?
NCT01637194 is a clinical study titled "Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer". This phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the abilit...
What is the current status of trial NCT01637194?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2008-11. Estimated completion is 2011-07.
What conditions does trial NCT01637194 study?
This clinical trial studies the following conditions: Recurrent Colon Cancer, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Mucoepidermoid Carcinoma of the Oral Cavity, Recurrent Basal Cell Carcinoma of the Lip, Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity.
What interventions are being tested in trial NCT01637194?
The interventions under investigation include: laboratory biomarker analysis (OTHER), cetuximab (BIOLOGICAL), pharmacological study (OTHER), everolimus (DRUG).
Who is sponsoring clinical trial NCT01637194?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01637194 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01637194's enrollment target sits among peer trials
12 10th of 10 the lowest of 10 other Recurrent Colon Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Colon 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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