Colorectal CancerPhase 3NCT00021281
Combination Chemotherapy With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
A Phase 3 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Jonsson Comprehensive Cancer Center 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. SU5416 may stop the growth of tumor cells by stopping blood flow to the tumor. 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?
- FOLFIRI regimen, fluorouracil and irinotecan hydrochloride
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to not given
- Phase
- Phase 3
- 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 confirmed adenocarcinoma of the colon or rectum Newly diagnosed or recurrent disease Measurable or evaluable metastatic disease that is previously untreated No known brain or leptomeningeal metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.8 times upper limit of normal (ULN) SGOT no greater than 5 times ULN Alkaline phosphatase no greater than 5 times ULN Lactate dehydrogenase no greater than 5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No myocardial infarction within the past 6 months No ongoing unstable angina No symptomatic congestive heart failure No serious uncontrolled cardiac dysrhythmia No stroke within the past 6 months Gastrointestinal: No active inflammatory bowel disease No significant bowel obstruction No chronic diarrhea grade 2 or greater Other: HIV negative No AIDS-related illness No known allergy to Cremaphor-containing products, irinotecan, fluorouracil, or to both warfarin (or similar oral anticoagulants) and low-molecular weight heparin No other malignancy within the past 5 years except nonmelanoma skin cancer No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior adjuvant antibody therapy, immunotherapy, gene therapy, vaccine therapy, or cytokine therapy No prior systemic biologic therapy for metastatic disease, including antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or angiogenesis inhibitors (e.g., SU5416, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody) No concurrent antibody therapy, immunotherapy, gene therapy, vaccine therapy, or angiogenesis inhibitors No concurrent sargramostim (GM-CSF) Chemotherapy: At least 6 months since prior adjuvant chemotherapy (e.g., fluorouracil, leucovorin calcium, levamisole, irinotecan, oxaliplatin, capecitabine, fluorouracil-uracil, or other cytotoxic agents) No prior systemic chemotherapy for metastatic disease No prior intra-arterial cytotoxic chemotherapy for metastatic disease No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: At least 6 months since prior adjuvant radioimmunotherapy or radiotherapy and recovered No concurrent radiotherapy Surgery: Recovered from prior surgery Other: At least 6 months since other prior adjuvant therapy No other prior systemic anticancer therapy for metastatic disease No other concurrent anticancer therapy No other concurrent experimental drugs No concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. SU5416 may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether combination chemotherapy will be more effective with or without SU5416 in treating metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without SU5416 in treating patients who have metastatic colorectal cancer.
Read the detailed description
OBJECTIVES: I. Compare the survival of patients with previously untreated metastatic colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan with or without SU5416. II. Compare the antitumor efficacy of these regimens in these patients. III. Evaluate the additional measures of clinical benefit in patients treated with these regimens. IV. Determine the relative safety profile of these regimens in these patients. V. Assess quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), baseline lactate dehydrogenase (normal vs elevated), and treatment regimen. Patients are randomized to 1 of 2 treatment arms by 2 different regimens (Saltz vs de Gramont). Regimen I (Saltz): Arm IA: Patients receive SU5416 IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Patients also receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 5-10 minutes, and fluorouracil IV over 5-10 minutes on days 1, 8, 15, and 22. Arm IIA: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in arm I. Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Regimen II (de Gramont): Arm IB: Patients receive SU5416 as in arm IA. Patients also receive irinotecan IV over 30-90 minutes on days 1, 15, and 29 and leucovorin calcium IV over 2 hours and fluorouracil IV over 2 hours on days 1, 2, 15, 16, 29, and 30. Arm IIB: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in arm IB. Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then at the end of treatment. Patients are followed at 1 month and then every 2 months for 4 years.
PROJECTED ACCRUAL: A total of 1,270 patients (635 per treatment arm) will be accrued for this study within 2 years.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFIRI regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium, semaxanib
- 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.
FOLFIRI regimenDrug
fluorouracilDrug
semaxanibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2004 (estimated)
- Study startDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Lee S. Rosen, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021281
- Sponsor's protocol ID
- CDR0000068766
- Other IDs
- UCLA-001003701, SUGEN-SU5416.035, NCI-G01-1980
- Status last verified
- Sep 2001
- First submitted
- 11 Jul 2001
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label Multicenter, International Study Comparing The Combination Of SU5416/Irinotecan/5-Fluorouracil/Leucovorin Versus Irinotecan/Fluorouracil/Leucovorin Alone As First-Line Therapy Of Patient With Previously Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00021281
- Acronym / sponsor ID
- CDR0000068766
- 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 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- First posted
- 13 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. SU5416 may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether combination chemotherapy will be more effective with or without SU5416 in treating metastatic colorectal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without SU5416 in treating patients who have metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Compare the survival of patients with previously untreated metastatic colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan with or without SU5416. II. Compare the antitumor efficacy of these regimens in these patients. III. Evaluate the additional measures of clinical benefit in patients treated with these regimens. IV. Determine the relative safety profile of these regimens in these patients. V. Assess quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), baseline lactate dehydrogenase (normal vs elevated), and treatment regimen. Patients are randomized to 1 of 2 treatment arms by 2 different regimens (Saltz vs de Gramont). Regimen I (Saltz): Arm IA: Patients receive SU5416 IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Patients also receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 5-10 minutes, and fluorouracil IV over 5-10 minutes on days 1, 8, 15, and 22. Arm IIA: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in arm I. Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Regimen II (de Gramont): Arm IB: Patients receive SU5416 as in arm IA. Patients also receive irinotecan IV over 30-90 minutes on days 1, 15, and 29 and leucovorin calcium IV over 2 hours and fluorouracil IV over 2 hours on days 1, 2, 15, 16, 29, and 30. Arm IIB: Patients receive irinotecan, leucovorin calcium, and fluorouracil as in arm IB. Treatment in both arms repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the beginning of each course, and then at the end of treatment. Patients are followed at 1 month and then every 2 months for 4 years.
PROJECTED ACCRUAL: A total of 1,270 patients (635 per treatment arm) will be accrued for this study within 2 years.
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 |
|---|---|---|
| FOLFIRI regimen | Drug | – |
| fluorouracil | Drug | – |
| irinotecan hydrochloride | Drug | – |
| leucovorin calcium | Drug | – |
| semaxanib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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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.
Lee S. Rosen, MD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFIRI regimen, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by Jonsson Comprehensive Cancer Center 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: status not confirmed, as of the sponsor's last update on 19 Dec 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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 19 Dec 2013.