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Phase 2, Multi-center, Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer of the Bile Duct, Gallbladder Cancer

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Trial Information

Phase 2, Multi-center, Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer


Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial
response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as
the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic
cholangiocarcinoma or other biliary tract tumors treated with GM-CT-01 plus 5-Fluorouracil
(DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive
days of treatment followed by a 24-day follow-up period.


Inclusion Criteria:



1. 18 years of age or older.

2. 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.

3. 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.

4. 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.

5. Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.

6. 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.

7. ECOG performance status less than or equal to 2.

8. Life expectancy greater or equal to 3 months.

Exclusion Criteria:

1. Central nervous system metastasis.

2. Bony metastasis as the sole metastasis.

3. 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.

4. 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.

5. Active infection that requires treatment with systemic antibiotic, anti- fungal.
or anti-viral therapy.

6. 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.

7. Unresolved biliary tract obstruction.

8. Known or clinically suspected infection with HIV.

9. Subject has a known intolerance to 5- FU.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. CR, PR, SD and progressive disease (PD) as defined by RECIST criteria.

Outcome Time Frame:

When 18 valuable patients have completed 2nd CT

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

DAVFU-007

NCT ID:

NCT00386516

Start Date:

September 2006

Completion Date:

June 2009

Related Keywords:

  • Cancer of the Bile Duct
  • Gallbladder Cancer
  • cholangiocarcinoma
  • bile duct
  • biliary
  • intra-hepatic
  • extra-hepatic
  • gall bladder
  • cancer
  • carcinoma
  • metastatic
  • metastasis
  • advanced
  • recurrent
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms

Name

Location

Boston Medical CenterBoston, Massachusetts  02118
Barrett Cancer CenterCincinnati, Ohio  45267-0502
University of Michigan, Comprehensive Cancer CenterAnn Arbor, Michigan  48109