Suspended

Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

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What is being tested

Aroplatin (Liposomal NDDP) in combination with capecitabine

Drug
Who is being recruted

Colorectal Neoplasms

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional

See protocol details

Summary

Principal SponsorAronex Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleA 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 
Principal SponsorAronex Pharmaceuticals
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
105 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Neoplasms
Criteria

Inclusion criteria: * 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; * 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. Exclusion criteria: * 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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
SuspendedNo study centers