Colorectal CancerPhase 2NCT00017082
Oxaliplatin in Treating Patients With Recurrent Metastatic Colorectal Cancer
A Phase 2 study testing oxaliplatin in people with Colorectal Cancer, run by Prologue Research International at 10 sites 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. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent metastatic colorectal cancer. 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?
- oxaliplatin
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Apr 2001to Dec 2010
- 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 or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum Not amenable to potentially curative treatment (e.g., inoperable metastatic disease) Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease, including the following: First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine OR Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above At least 1 unidimensionally measurable lesion At least 20 mm by CT scan or MRI At least 10 mm by spiral CT scan
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within the past 6 months No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy No history of allergies to drugs containing platinum No known concurrent peripheral neuropathy No diabetes No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy, including irinotecan, for metastatic or recurrent disease and recovered No other prior first-line chemotherapy agents for metastatic or recurrent disease No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesions unless documented disease progression within the radiation portal Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary or metastatic disease and recovered Other: No prior investigational anticancer drug administered with irinotecan No other concurrent investigational drugs
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
Memphis Cancer Center
Memphis, Tennessee, 38119
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Raleigh Hematology/Oncology Associates - Wake Practice
Raleigh, North Carolina, 27609
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: A Multicenter, Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Read the detailed description
OBJECTIVES: I. Determine the overall response rate, onset and duration of partial and complete responses, and duration of stable disease in patients with recurrent metastatic colorectal cancer treated with oxaliplatin. II. Determine the overall survival of patients treated with this drug. III. Determine the proportion of patients with tumor-related symptomatic improvement and time to tumor-related symptomatic worsening in patients treated with this drug. IV. Determine the time to disease progression in patients treated with this drug. V. Determine the proportion of patients achieving stable disease when treated with this drug. VI. Determine the safety of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 120 minutes on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression. Patients are followed at 30 days and then every 8 weeks for 10 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- 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.
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2004 (estimated)
- Study startApr 2001
- Primary completionJun 2003
- Study completionDec 2010
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.
- 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
- Prologue Research International
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard A. Gams, MD, Study chair, Prologue Research International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017082
- Sponsor's protocol ID
- PROLOGUE-EFC4759
- Other IDs
- CDR0000068647, SANOFI-EFC4759
- Status last verified
- Dec 2010
- First submitted
- 6 Jun 2001
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00017082
- Acronym / sponsor ID
- PROLOGUE-EFC4759
- 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
- Prologue Research InternationalIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Jun 2003 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Jan 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.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the overall response rate, onset and duration of partial and complete responses, and duration of stable disease in patients with recurrent metastatic colorectal cancer treated with oxaliplatin. II. Determine the overall survival of patients treated with this drug. III. Determine the proportion of patients with tumor-related symptomatic improvement and time to tumor-related symptomatic worsening in patients treated with this drug. IV. Determine the time to disease progression in patients treated with this drug. V. Determine the proportion of patients achieving stable disease when treated with this drug. VI. Determine the safety of this drug in this patient population.
OUTLINE: This is a multicenter study. Patients receive oxaliplatin IV over 120 minutes on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression. Patients are followed at 30 days and then every 8 weeks for 10 months.
PROJECTED ACCRUAL: A total of 50 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 |
|---|---|---|
| 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 26 Jun 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.
Richard A. Gams, MD study chair
Prologue Research International
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin in people with Colorectal Cancer, run by Prologue Research International at 10 sites 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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 26 Jun 2013.