- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00499850
Phase I FOLFOX Combination
August 24, 2016 updated by: Genzyme, a Sanofi Company
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
East Melbourne, Australia
- Research Site
-
Footscray, Australia
- Research Site
-
Heidelberg, Australia
- Research Site
-
Parkville, Australia
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)
- WHO performance status 0-1
- one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques
Exclusion Criteria:
- Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable
- last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment
- prior unanticipated severe reaction to oxaliplatin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
Time Frame: Assessed at each visit
|
Assessed at each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
July 10, 2007
First Submitted That Met QC Criteria
July 11, 2007
First Posted (Estimate)
July 12, 2007
Study Record Updates
Last Update Posted (Estimate)
August 25, 2016
Last Update Submitted That Met QC Criteria
August 24, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Micronutrients
- Vitamins
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
Other Study ID Numbers
- D4200C00037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Colorectal Carcinoma
-
University of ChicagoVerastem, Inc.RecruitingColorectal Cancer | Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Advanced Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Colorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Advanced Microsatellite Stable Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
Zhejiang UniversityRecruitingAdvanced Colorectal Cancer | Advanced Hepatocellular Carcinoma | Advanced Gastric Cancer | Advanced Pancreatic CancerChina
-
Guang'anmen Hospital of China Academy of Chinese...RecruitingAdvanced Colorectal CarcinomaChina
-
Apros Therapeutics, IncCompletedAdvanced Colorectal CarcinomaUnited States
-
Cancer Institute and Hospital, Chinese Academy...RecruitingLocally Advanced Colorectal CarcinomaChina
-
Binhui Biopharmaceutical Co., Ltd.TerminatedAdvanced Colorectal CarcinomaChina
-
Wuhan Union Hospital, ChinaNot yet recruitingRecurrent Colorectal Carcinoma | Advanced Colorectal CarcinomaChina
-
National Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic... and other conditionsUnited States
-
4SC AGCompletedAdvanced Colorectal CarcinomaGermany
Clinical Trials on 5-Fluorouracil
-
The Netherlands Cancer InstituteCompleted
-
The Netherlands Cancer InstituteCompleted
-
The Cleveland ClinicNational Cancer Institute (NCI)TerminatedActinic Keratosis | Organ or Tissue Transplant; ComplicationsUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownSquamous Cell Carcinoma of the Head and NeckChina
-
National Cancer Institute (NCI)CompletedStage IV Colon Cancer | Stage IV Rectal Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Adenocarcinoma of the Rectum | Adenocarcinoma of the ColonUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)TerminatedMucinous Adenocarcinoma of the Rectum | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal CancerUnited States
-
Peking Union Medical College HospitalRecruitingRectal Cancer | Colon Cancer | Chemotherapy Effect | PTC | Exon MutationChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedColorectal Cancer | Metastatic CancerUnited States
-
Singapore National Eye CentreSingapore Eye Research Institute; Nanchang UniversityCompletedGlaucoma | Wound Healing | TrabeculectomySingapore