Colorectal CancerPhase 2NCT00005833
S9923 R115777 in Treating Patients With Advanced Colorectal Cancer
A Phase 2 study testing R115777 in people with Colorectal Cancer, run by SWOG Cancer Research Network at 12 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 R115777 in treating patients who have recurrent or advanced 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?
- R115777
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2000to Jul 2006
- 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 advanced colorectal adenocarcinoma Well differentiated OR Moderately well differentiated OR Poorly differentiated Distant metastases not surgically curable Measurable disease No prior treatment for disseminated disease No known brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte 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 or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception Must be able to swallow or receive enteral medications through gastrostomy feeding tube No intractable nausea or vomiting No other prior malignancy for the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior adjuvant immunotherapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior adjuvant chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No more than 25% of total area of bone marrow irradiated No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered Other: No concurrent proton pump inhibitors No other concurrent anticancer therapy
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
CCOP - Columbus
Columbus, Ohio, 43206
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Greenville
Greenville, South Carolina, 29615
CCOP - Kansas City
Kansas City, Missouri, 64131
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
University of California Davis Medical Center
Sacramento, California, 95817
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
About this study
Official title: A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer
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 R115777 in treating patients who have recurrent or advanced colorectal cancer.
Read the detailed description
OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated colorectal cancer who have been previously treated for advanced disease. II. Assess the time to treatment failure and survival of these patients with this treatment regimen. III. Determine the frequency and severity of toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.
- Conditions
- Colorectal Cancer
- Being tested
- R115777
- 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.
R115777Drug
Also called NSC-702818
300mg P.O. BID.
| Study group | Role | What they receive |
|---|---|---|
| R115777 | Experimental | R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days. Receives: Drug: R115777 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed complete and partial response rate to R115777
Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.
Measured: Once every 8 weeks until progression
Secondary outcomes (2)
Time to treatment failure and survival
To assess time to treatment failure and survival in this group of patients.
Measured: Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration
Frequency & severity of toxicities
To assess the frequency and severity of toxicities associated with this treatment.
Measured: Weekly for 8 weeks and then once every 4 weeks until progression
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 startJun 2000
- Primary completionJul 2006
- Study completionJul 2006
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 SWOG Cancer Research NetworkThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert P. Whitehead, MD, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005833
- Sponsor's protocol ID
- CDR0000067847
- Other IDs
- S9923, U10CA032102
- Status last verified
- Jun 2012
- First submitted
- 2 Jun 2000
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Whitehead RP, McCoy S, Macdonald JS, Rivkin SE, Neubauer MA, Dakhil SR, Lenz HJ, Tanaka MS, Abbruzzese JL; Southwest Oncology Group. Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study. Invest New Drugs. 2006 Jul;24(4):335-41. doi: 10.1007/s10637-005-4345-3.
PubMed 16683076
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00005833
- Acronym / sponsor ID
- CDR0000067847
- 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
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2000
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (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.
PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or advanced colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated colorectal cancer who have been previously treated for advanced disease. II. Assess the time to treatment failure and survival of these patients with this treatment regimen. III. Determine the frequency and severity of toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R115777 | Experimental | Drug: R115777R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days. |
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 |
|---|---|---|
| R115777Also: NSC-702818300mg P.O. BID. | Drug | R115777 |
Primary outcome
Confirmed complete and partial response rate to R115777
Time frame: Once every 8 weeks until progression
Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.
2 secondary outcomes
Time to treatment failure and survival
Time frame: Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration
Frequency & severity of toxicities
Time frame: Weekly for 8 weeks and then once every 4 weeks until progression
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 14 Jun 2012.
- Results publication: PubMed 16683076Whitehead RP, McCoy S, Macdonald JS, Rivkin SE, Neubauer MA, Dakhil SR, Lenz HJ, Tanaka MS, Abbruzzese JL; Southwest Oncology Group. Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study. Invest New Drugs. 2006 Jul;24(4):335-41. doi: 10.1007/s10637-005-4345-3.
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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.
Robert P. Whitehead, MD study chair
University of Texas
12 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 R115777 in people with Colorectal Cancer, run by SWOG Cancer Research Network at 12 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 14 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does the primary outcome measure?
Confirmed complete and partial response rate to R115777 (time frame: Once every 8 weeks until progression). 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 NCT00005833, 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 14 Jun 2012.