Colorectal CancerPhase 2NCT00276861
Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer
A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Colorectal Cancer, run by University of Miami at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- gemcitabine hydrochloride and oxaliplatin
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the colon
- Metastatic or recurrent disease
- Redocumentation of tumor histology or cytology prior to protocol therapy is not required if documented tumor was confirmed prior to initial therapy
- Measurable disease
- Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be repetitively assessed by physical examination
- Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions, and positive bone marrow biopsies are not considered measurable or evaluable lesions
- Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS disease is not required
- Must have received at least one prior chemotherapy regimen (with or without radiotherapy)
- One of the prior regimens must include irinotecan hydrochloride, fluorouracil, and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine
- Previous therapy with C-225 and/or bevacizumab is allowed
- .
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocyte count ≥1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin < 1.5 mg/dL
- SGOT ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase < 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious medical or psychiatric illness that would render chemotherapy unsafe
- No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer, low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of the breast
- No clinical AIDS or known positive HIV serology
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- No investigational agent for at least 30 days prior to study entry
- No chemotherapy within the past 3 weeks
- No radiotherapy for palliation within the past 2 weeks prior to study entry
- No prior oxaliplatin or gemcitabine hydrochloride
- No concurrent participation in another clinical trial
- No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
- Determine the duration of response (complete or partial) in patients treated with this regimen.
- Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving this regimen.
- Evaluate the toxicity associated with the administration of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
- Conditions
- Colorectal Cancer
- Being tested
- gemcitabine hydrochloride, oxaliplatin
- Keywords
- adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate as Measured by RECIST Criteria
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
Measured: 4 - 6 months
Secondary outcomes (1)
Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment
Number of months from time of enrollment to the date of first documented progression or date of death.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionMay 2008
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of MiamiThe 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
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caio Max S. Rocha Lima, MD, Study chair, University of Miami Sylvester Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276861
- Sponsor's protocol ID
- 20030655
- Other IDs
- SCCC-2003110, WIRB-20050993
- Status last verified
- Dec 2016
- First submitted
- 12 Jan 2006
- Last updated
- 8 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lopes G, Quesada J, Ahn E, Flores A, Ribeiro A, Rocha-Lima CM. Oxaliplatin and fixed-rate infusional gemcitabine in the second-line treatment of patients with metastatic colon cancer: final results of a Phase II trial prematurely closed as a result of poor accrual. Clin Colorectal Cancer. 2007 Sep;6(9):641-5. doi: 10.3816/CCC.2007.n.032.
PubMed 17945036
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin And Fixed Rate Infusion Gemcitabine as Second Line Therapy for Patients With Metastatic Colon Cancer
- ClinicalTrials.gov ID
- NCT00276861
- Acronym / sponsor ID
- 20030655
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Posted 26 Feb 2013
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, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin.
Secondary
- Determine the overall and failure-free survival of patients treated with the chemotherapy regimen.
- Determine the duration of response (complete or partial) in patients treated with this regimen.
- Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of > 5 U/mL after receiving this regimen.
- Evaluate the toxicity associated with the administration of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Response Rate as Measured by RECIST Criteria
Time frame: 4 - 6 months
Complete Response (CR) or Partial Response (PR) as defined by RECIST v 1.0 criteria.
1 secondary outcome
Time to Progression as Measured by the Kaplan Meyer Curve at Completion of Study Treatment
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17945036Lopes G, Quesada J, Ahn E, Flores A, Ribeiro A, Rocha-Lima CM. Oxaliplatin and fixed-rate infusional gemcitabine in the second-line treatment of patients with metastatic colon cancer: final results of a Phase II trial prematurely closed as a result of poor accrual. Clin Colorectal Cancer. 2007 Sep;6(9):641-5. doi: 10.3816/CCC.2007.n.032.
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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.
Caio Max S. Rocha Lima, MD study chair
University of Miami Sylvester 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 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Colorectal Cancer, run by University of Miami 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: stopped early, as of the sponsor's last update on 8 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 26 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Response Rate as Measured by RECIST Criteria (time frame: 4 - 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276861, 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 8 Feb 2017.