Colorectal NeoplasmsPhase 2NCT00043199
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
A Phase 2 study testing Aroplatin (Liposomal NDDP, L-NDDP) in people with Colorectal Neoplasms, run by Aronex Pharmaceuticals at 2 sites in United States.
Trial summary
To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy. 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, L-NDDP)
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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
Who may be able to join
- Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC);
- Measurable disease (RECIST criteria);
- Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan;
- ECOG performance score of 0-2;
- Adequate hematopoietic, liver and renal function;
- Adequate cardiac function (maximum of class II, NYHA);
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- Women of child-bearing potential must have a negative urine or serum pregnancy test;
- Signed written informed consent;
- Subjects must be willing to to be followed during the course of treatment/observation and follow-up.
Who cannot join
- Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
- Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study;
- Prior therapy with oxaliplatin;
- Known brain metastases;
- Active, uncontrolled infection or other serious medical illnesses;
- Subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arizona Cancer Center
Tucson, Arizona, 85724
University Medical Center
Tucson, Arizona, 85724
About this study
Official title: A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan
To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.
Read the detailed description
Primary Objective:
- To determine response rate (RR; complete and partial response[CR,PR] and duration after therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan.
Secondary Objective:
- To determine safety and tolerability of the Aroplatin therapy.
This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks with individual dose escalations and adjustments for toxicity.
- Conditions
- Colorectal Neoplasms
- Being tested
- Aroplatin (Liposomal NDDP, L-NDDP)
- 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, L-NDDP)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2002 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Aronex Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043199
- Sponsor's protocol ID
- C-726-01
- Status last verified
- Apr 2004
- First submitted
- 6 Aug 2002
- 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 II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan
- ClinicalTrials.gov ID
- NCT00043199
- Acronym / sponsor ID
- C-726-01
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Neoplasms, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumor, Neoplasms, Colorectal, Unresectable, Metastatic, Refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Aronex PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 Aug 2002 (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.
To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.
Detailed description
Primary Objective:
- To determine response rate (RR; complete and partial response[CR,PR] and duration after therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan.
Secondary Objective:
- To determine safety and tolerability of the Aroplatin therapy.
This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks with individual dose escalations and adjustments for toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (9 listed)
- Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC);
- Measurable disease (RECIST criteria);
- Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan;
- ECOG performance score of 0-2;
- Adequate hematopoietic, liver and renal function;
Key exclusion criteria (6 listed)
- Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
- Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study;
- Prior therapy with oxaliplatin;
- Known brain metastases;
- Active, uncontrolled infection or other serious medical illnesses;
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, L-NDDP) | 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.
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 Aroplatin (Liposomal NDDP, L-NDDP) in people with Colorectal Neoplasms, run by Aronex Pharmaceuticals 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?
The sponsor lists 9 inclusion and 6 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.
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. 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?
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.