Colorectal CancerPhase 2NCT00004102
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
A Phase 2 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFOX regimen, fluorouracil and leucovorin calcium
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Nov 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven advanced adenocarcinoma of the colon or rectum No prior systemic chemotherapy OR Adjuvant chemotherapy only, completed 6 months prior to study and with subsequent development of recurrent disease At least 1 bidimensionally measurable lesion No CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL (no greater than 5.0 mg/dL if due to intrahepatic biliary obstruction not amenable to biliary decompression, if approved by the protocol investigator) SGOT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No neurologic disease No active or uncontrolled infection No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No medical or psychiatric disorders that would prevent compliance
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for malignant disease Surgery: Recovered from any prior surgery Other: At least 30 days since other prior investigational agent No other concurrent investigational agents No concurrent anticancer agents
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
About this study
Official title: A Phase II Trial of Eloxatin in Combination With 5-Fluorouracil and Leucovorin in Patients With Advanced Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.
Read the detailed description
OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum.
OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29, and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses upon approval by the sponsor. Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX regimen, fluorouracil, leucovorin calcium, oxaliplatin
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
fluorouracilDrug
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study startJan 1999
- Primary completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Howard S. Hochster, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004102
- Sponsor's protocol ID
- CDR0000067321
- Other IDs
- P30CA016087, NYU-9863, SANOFI-EFC7132, NCI-G99-1593
- Status last verified
- Mar 2011
- First submitted
- 10 Dec 1999
- Last updated
- 28 Mar 2011
- Results posted
- No
Publications
Hochster H, Chachoua A, Speyer J, Escalon J, Zeleniuch-Jacquotte A, Muggia F. Oxaliplatin with weekly bolus fluorouracil and low-dose leucovorin as first-line therapy for patients with colorectal cancer. J Clin Oncol. 2003 Jul 15;21(14):2703-7. doi: 10.1200/JCO.2003.02.071.
PubMed 12860947
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Eloxatin in Combination With 5-Fluorouracil and Leucovorin in Patients With Advanced Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00004102
- Acronym / sponsor ID
- CDR0000067321
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 1999
- Primary completion
- Nov 2001 (actual)
- First posted
- 12 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.
Detailed description
OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum.
OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29, and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses upon approval by the sponsor. Patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOX regimen | Drug | – |
| fluorouracil | Drug | – |
| leucovorin calcium | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
- Results publication: PubMed 12860947Hochster H, Chachoua A, Speyer J, Escalon J, Zeleniuch-Jacquotte A, Muggia F. Oxaliplatin with weekly bolus fluorouracil and low-dose leucovorin as first-line therapy for patients with colorectal cancer. J Clin Oncol. 2003 Jul 15;21(14):2703-7. doi: 10.1200/JCO.2003.02.071.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard S. Hochster, MD study chair
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX regimen, fluorouracil and leucovorin calcium in people with Colorectal Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.