Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and … (NCT00386516) | Clinical Trial Compass
WithdrawnPhase 2
Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer
Stopped: Financing and re-organization
United States0Started 2006-09
Plain-language summary
The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall bladder and bile duct cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older.
. Histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
. Prior neo-adjuvant or adjuvant therapy (including radiation therapy) is allowed provided it was completed at least 4 weeks before documented disease recurrence or metastasis.
. Discontinuation of radiation therapy at least 3 weeks prior to Day 1 of Cycle 1. Radiation therapy will not be allowed while a subject is on study except for palliative radiation therapy to non-target lesions administered following consultation with the Medical Monitor.
. Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)
Timeframe: When 18 valuable patients have completed 2nd CT
2
Stable disease (SD) rate and progression-free survival (PFS) times
Timeframe: When 18 valuable patients have completed 2nd CT
. Nne or more measurable target lesion(s) according to RECIST. Measurable lesion(s) must be outside of previous radiation field or demonstrate clear radiographic progression on serial imaging if within previous treatment field.
. ECOG performance status less than or equal to 2.
. Life expectancy greater or equal to 3 months.
Exclusion criteria
. Central nervous system metastasis.
. Bony metastasis as the sole metastasis.
. Received prior chemotherapy or anti-angiogenesis agents including bevacizumab or erbitux or radiation therapy other than in a neo-adjuvant or adjuvant setting. No concomitant chemotherapy, anti-tumor biologic therapy, or radiation therapy is allowed.
. If nitrosoureas or mitomycin C were used as neo-adjuvant or adjuvant therapy, then at least 6 weeks should have elapsed prior to treatment with DAVFU.
. Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.
. Congestive heart failure (Class III or IV in the NYHA functional classification system) or any other medical condition that would preclude the IV administration of up to approximately 200 mL of fluid over 30-60 minutes.
. Unresolved biliary tract obstruction.
. Known or clinically suspected infection with HIV.