Colorectal NeoplasmsPhase 1/2NCT00081536
Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
A Phase 1/2 study testing Aroplatin (Liposomal NDDP) in combination with capecitabine in people with Colorectal Neoplasms, run by Aronex Pharmaceuticals.
Trial summary
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Aroplatin (Liposomal NDDP) in combination with capecitabine
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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
Who may be able to join
- Histologically confirmed colorectal cancer: unresectable local recurrence or distant metastases;
- Measurable disease (RECIST criteria);
- Refractory to 5-FU / leucovorin and irinotecan as described below;
- No prior therapy with oxaliplatin, any other platinum or capecitabine;
- ECOG score 0-2 (Karnofsky 100-70%);
- Life expectancy of greater then or equal to 5 months;
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- Adequate hematopoietic, liver and renal function;
- Women of child-bearing potential have to practice adequate contraception;
- Signed written informed consent;
- Subjects must be willing to be followed during the course of treatment/observation and follow-up.
- Refractory metastatic colorectal cancer
- The following subjects are regarded refractory to treatment:
- Those with progression while receiving 5-FU/LV/irinotecan;
- Those with progression on irinotecan after prior 5-FU/LV treatment;
- Progression within six months of adjuvant 5-FU/LV/irinotecan;
- Progression within six months of adjuvant 5-FU/LV followed by progression on irinotecan
- Subjects must have received at least one or more commonly used 5-FU/leucovorin and irinotecan regimens. Prior adjuvant therapy is allowed including 5-FU/leucovorin or other fluoropyrimidines except capecitabine and irinotecan.
Who cannot join
- Previously diagnosed brain metastases if symptomatic and requiring active therapy;
- Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
- Concurrent chemotherapy or immunotherapy;
- Prior therapy for colorectal cancer within one month of admission to the present study;
- Primary or secondary immunodeficiency or use of corticosteroids or other immunosuppressive medication;
- Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study;
- Women must not be pregnant or breast-feeding;
- No participation in any clinical trial involving investigational drugs within 1 month from enrollment into the present study.
About this study
Official title: A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.
Read the detailed description
Phase I Primary Objective:
- Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan.
Phase II Primary Objective:
- Evaluate the response proportion and duration with Aroplatin/capecitabine therapy.
Phase II Secondary Objective:
- Evaluate the frequency of adverse events.
- Conditions
- Colorectal Neoplasms
- Being tested
- Aroplatin (Liposomal NDDP) in combination with capecitabine
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumor, Neoplasms, Colorectal, Unresectable, Metastatic, Refractory
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroplatin (Liposomal NDDP) in combination with capecitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants
Sponsor and investigators
- Lead sponsor
- Aronex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081536
- Sponsor's protocol ID
- C-726-03
- Status last verified
- Apr 2004
- First submitted
- 15 Apr 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan
- ClinicalTrials.gov ID
- NCT00081536
- Acronym / sponsor ID
- C-726-03
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumor, Neoplasms, Colorectal, Unresectable, Metastatic, Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants
- Lead sponsor
- Aronex PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 20 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.
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.
Detailed description
Phase I Primary Objective:
- Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan.
Phase II Primary Objective:
- Evaluate the response proportion and duration with Aroplatin/capecitabine therapy.
Phase II Secondary Objective:
- Evaluate the frequency of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed colorectal cancer: unresectable local recurrence or distant metastases;
- Measurable disease (RECIST criteria);
- Refractory to 5-FU / leucovorin and irinotecan as described below;
- No prior therapy with oxaliplatin, any other platinum or capecitabine;
- ECOG score 0-2 (Karnofsky 100-70%);
Key exclusion criteria (8 listed)
- Previously diagnosed brain metastases if symptomatic and requiring active therapy;
- Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
- Concurrent chemotherapy or immunotherapy;
- Prior therapy for colorectal cancer within one month of admission to the present study;
- Primary or secondary immunodeficiency or use of corticosteroids or other immunosuppressive medication;
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 |
|---|---|---|
| Aroplatin (Liposomal NDDP) in combination with capecitabine | 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aroplatin (Liposomal NDDP) in combination with capecitabine in people with Colorectal Neoplasms, run by Aronex Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 24 Jun 2005.