Chemotherapeutic Agent ToxicityPhase 2NCT00748215
Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
A Phase 2 study testing calcium aluminosilicate anti-diarrheal in people with Chemotherapeutic Agent Toxicity and Colorectal Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in treating and preventing diarrhea in patients receiving irinotecan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea
- What is being tested?
- calcium aluminosilicate anti-diarrheal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2009to 12 Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer
- Metastatic disease
- Scheduled to receive irinotecan hydrochloride alone or in combination with fluorouracil, cetuximab, leucovorin calcium, or other biological therapy (including bevacizumab)
- No uncontrolled brain metastasis
- Previously treated brain metastasis allowed
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) > 1,000/mm³
- Platelet count > 100,000/mm³
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST or SGOT) and/or alanine aminotransferase (ALT or SGPT) < 2.5 times ULN (< 5 times ULN if liver metastasis is present)
- Alkaline phosphatase < 2.5 times ULN
- Creatinine clearance > 35 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known UDP-glucuronosyltransferase 1A1 (UGT1A1) deficiency with homozygotes.
- No known history of Gilbert's disease
- No diarrhea > grade 1
- No serious illness or medical condition, including any of the following:
- Uncontrolled congestive heart failure
- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
- Uncontrolled arrhythmia
- Active angina pectoris
- Symptomatic heart disease according to New York Heart Association(NYHA) class II-IV
- No serious uncontrolled active infection
- No existing colostomy or ileostomy
- Not able to take and document oral study medications
- No history of allergies to irinotecan hydrochloride
- No history of significant neurological or psychiatric disorders that would preclude giving consent or participating in study treatment or follow up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior treatment for metastatic disease allowed
- At least 4 weeks since prior irinotecan
- More than 2 weeks since prior chemotherapy
- Irinotecan alone or in combination with other chemotherapy or biologic agents allowed
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- No concurrent medication schedule that does not permit a 2-hour window between administration of calcium aluminosilicate anti-diarrheal (CASAD) and other medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
About this study
Official title: Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer
RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in treating and preventing diarrhea in patients receiving irinotecan.
PURPOSE: This randomized phase II trial is studying CASAD to see how well it works compared with a placebo in treating and preventing diarrhea in patients with metastatic colorectal cancer receiving irinotecan.
Read the detailed description
OBJECTIVES:
Primary
- To compare the efficacy of calcium aluminosilicate anti-diarrheal (CASAD) versus placebo in reducing the incidence of grade 3 or 4 diarrhea in patients with metastatic colorectal cancer receiving an irinotecan-based chemotherapy regimen.
Secondary
- To compare stools per day in patients treated with these drugs.
- To compare chemotherapy dose reductions and delays due to diarrhea in patients treated with these drugs.
- To compare quality of life of patients treated with these drugs.
- To compare the safety of these drugs in these patients.
- To compare the incidence of grade 3 or 4 diarrhea in patients treated with these drugs.
OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy regimen (irinotecan hydrochloride in combination with fluorouracil and/or biologic therapy vs irinotecan hydrochloride alone). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who develop grade 3 or 4 diarrhea and are removed from the study may receive CASAD for an additional 6 weeks.
- Arm II: Patients receive oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who develop grade 3 or 4 diarrhea and are removed from the study may then receive CASAD for 6 weeks.
Patients undergo quality-of-life assessment at baseline and at weeks 3, 5, and 6.
After completion of study treatment, patients are followed for 30 days.
- Conditions
- Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea
- Being tested
- calcium aluminosilicate anti-diarrheal, placebo
- Keywords
- diarrhea, chemotherapeutic agent toxicity, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Diarrhea, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium aluminosilicate anti-diarrhealDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I: CASAD | Experimental | Oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks. Receives: Drug: calcium aluminosilicate anti-diarrheal |
| Arm II: Placebo | Placebo comparator | Oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Grade 3/4 Diarrhea
One hundred patients were randomized equally between CASAD and placebo arms in order to assess whether CASAD was efficacious in preventing grade 3/4 diarrhea within 6 weeks for each arm compared. Bayesian futility monitoring in the study with a recommendation to stop the trial for futility if it became clear that CASAD was not better than placebo.
Measured: First 6 weeks from baseline in initial intervention with CASAD or PLACEBO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study start4 Feb 2009
- Primary completion12 Aug 2014
- Study completion12 Aug 2014
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.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian K. Kee, MD, Study chair, M.D. Anderson Cancer CenterMichael J. Fisch, MD, MPH, FACP, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748215
- Sponsor's protocol ID
- MDA-2008-0005
- Other IDs
- MDA-2008-0005, CDR0000612205
- Status last verified
- Nov 2020
- First submitted
- 5 Sep 2008
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00748215
- Acronym / sponsor ID
- MDA-2008-0005
- Conditions
- Chemotherapeutic Agent Toxicity, Colorectal Cancer, Diarrhea
- Keywords
- diarrhea, chemotherapeutic agent toxicity, recurrent colon cancer, recurrent rectal cancer, stage IV colon cancer, stage IV rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Feb 2009 (actual)
- Primary completion
- 12 Aug 2014 (actual)
- Study completion
- 12 Aug 2014 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 2 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Calcium aluminosilicate anti-diarrheal (CASAD) may help treat and prevent diarrhea caused by irinotecan. It is not yet known whether CASAD is more effective than a placebo in treating and preventing diarrhea in patients receiving irinotecan.
PURPOSE: This randomized phase II trial is studying CASAD to see how well it works compared with a placebo in treating and preventing diarrhea in patients with metastatic colorectal cancer receiving irinotecan.
Detailed description
OBJECTIVES:
Primary
- To compare the efficacy of calcium aluminosilicate anti-diarrheal (CASAD) versus placebo in reducing the incidence of grade 3 or 4 diarrhea in patients with metastatic colorectal cancer receiving an irinotecan-based chemotherapy regimen.
Secondary
- To compare stools per day in patients treated with these drugs.
- To compare chemotherapy dose reductions and delays due to diarrhea in patients treated with these drugs.
- To compare quality of life of patients treated with these drugs.
- To compare the safety of these drugs in these patients.
- To compare the incidence of grade 3 or 4 diarrhea in patients treated with these drugs.
OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy regimen (irinotecan hydrochloride in combination with fluorouracil and/or biologic therapy vs irinotecan hydrochloride alone). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who develop grade 3 or 4 diarrhea and are removed from the study may receive CASAD for an additional 6 weeks.
- Arm II: Patients receive oral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who develop grade 3 or 4 diarrhea and are removed from the study may then receive CASAD for 6 weeks.
Patients undergo quality-of-life assessment at baseline and at weeks 3, 5, and 6.
After completion of study treatment, patients are followed for 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I: CASAD | Experimental | Drug: calcium aluminosilicate anti-diarrhealOral calcium aluminosilicate anti-diarrheal (CASAD) 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may receive CASAD for an additional 6 weeks. |
| Arm II: Placebo | Placebo comparator | Other: placeboOral placebo 4 times daily for 6 weeks in the absence of disease progression or unacceptable toxicity. Participants who develop grade 3 or 4 diarrhea may then receive CASAD for 6 weeks. |
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 |
|---|---|---|
| calcium aluminosilicate anti-diarrhealGiven orally | Drug | Arm I: CASAD |
| placeboGiven orally | Other | Arm II: Placebo |
Primary outcome
Number of Participants With Grade 3/4 Diarrhea
Time frame: First 6 weeks from baseline in initial intervention with CASAD or PLACEBO
One hundred patients were randomized equally between CASAD and placebo arms in order to assess whether CASAD was efficacious in preventing grade 3/4 diarrhea within 6 weeks for each arm compared. Bayesian futility monitoring in the study with a recommendation to stop the trial for futility if it became clear that CASAD was not better than placebo.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Brian K. Kee, MD study chair
M.D. Anderson Cancer Center
Michael J. Fisch, MD, MPH, FACP study chair
M.D. Anderson Cancer Center
2 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 calcium aluminosilicate anti-diarrheal in people with Chemotherapeutic Agent Toxicity and Colorectal Cancer, run by M.D. Anderson Cancer Center at 2 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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 2 Dec 2020). 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?
Number of Participants With Grade 3/4 Diarrhea (time frame: First 6 weeks from baseline in initial intervention with CASAD or PLACEBO). It is what the study was designed to measure, not a finding.
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 2 Dec 2020.