Efficacy of Imatinib and 5-FU/Leucovorin in Patients With Advanced Carcinoma of the Gallbladder and Bile Duct

NCT01153750 | Completed Phase 2

• 1 other identifier: TUD-Glivec-012
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

Brief Summary

To test the efficacy of a combination chemotherapy of imatinib and 5-FU in advanced or metastatic cholangiocellular carcinoma.

Conditions

Advanced or Metastatic Cholangiocellular Carcinoma and Bile Duct

Keywords

cholangiocellular carcinoma; bile duct cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

Secondary Outcomes (5)

• Progression-free survival (PFS)

• Response rate (RR)

• Overall survival

• Toxicity

• Evaluation of molecular predictive markers for response and toxicity

Study Arms (1)

Glivec and 5-Fluorouracil/Leucovorin

EXPERIMENTAL

All patients will receive Glivec® 600 mg once daily without dose escalation. Glivec® will be given on day -4, -3, -2, -1, 1, 2, 3 and 4. There will be no day "0". Patients will also receive 5-FU (2000mg/qm 24hc.i. d1 + d2) and leucovorin (200mg/qm 2h-infusion) qd15.

Drug: Glivec

Interventions

Glivec DRUG

Glivec and 5-Fluorouracil/Leucovorin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/Cytologically confirmed diagnosis of advanced / metastatic carcinoma of the gallbladder or bile duct, which is unresectable or metastatic and therefore incurable with any conventional multimodality approach
• Performance status 0, 1 or 2 (ECOG)
• Written, voluntary informed consent
• Age \> 18 years
• Adequate bone marrow function (Granulocytes \> 1,5 x 109/l, Hb \> 10 g/dl, Platelets \> 100 x 109/l)
• Adequate hepatic and renal function ( bilirubin \< 1,25 x upper normal limit or \< 1,5 x upper normal limit if hyperbilirubinemia is related to underlying disease, ALAT + ASAT \< 1,5 x upper normal limit, in case of liver metastases \< 5 x upper normal limit, creatinine \< 1,25 x upper normal limit)
• Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Female patients with child-bearing potential must perform a highly effective barrier method of birth control throughout the study with a proven efficacy of \>99%. The contraception treatment should be performed for an additional six month following discontinuation from study treatment. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following discontinuation of study drug.

You may not qualify if:

• Patient has received any other investigational agents within 28 days of first day of study drug dosing.
• Patient is \< 5 years free of another primary malignancy, except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
• Female patients who are pregnant or breast-feeding.
• Patient has a severe and/or uncontrolled medical disease.
• The concurrent use of warfarin or acetaminophen are not allowed with imatinib mesylate and need to be replaced by other medications (e.g. by low molecular heparins in case of warfarin).
• Radiotherapy or any major abdominal or thoracic surgery \< 4 weeks before study entry (excluding diagnostic biopsy or port implantation)
• Patient has received neoadjuvant imatinib mesylate or fluoropyrimidines prior to study entry
• Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
• Known incompatibility of imatinib,5-FU, or leucovorin
• Known brain metastases
• Concurrent systemic chemotherapy, immunotherapy, hormone therapy
• History of severe psychiatric illness
• Drug- or alcohol abuse
• Patient has know chronic liver disease (i.e., chronic active hepatitis, and cirrhosis)
• Patients with dihydropyrimidine dehydrogenase deficiency (i.e. Treatment with Zostex)

Sponsors & Collaborators

• University Hospital Dresden: lead

Study Sites (8)

Krankenhaus Nordwest

Frankfurt am Main, Hesse, 60488, Germany

Location

University Hospital

Dresden, Saxony, 01307, Germany

Location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Onkologische Schwerpunktpraxis Eppendorf

Hamburg, 20249, Germany

Location

Staedtisches Klinikum Magdeburg

Magdeburg, 36130, Germany

Location

Johannes-Gutenberg-Universität Mainz, Medical Department I

Mainz, 55131, Germany

Location

Ruppiner Kliniken GmbH

Neuruppin, 16816, Germany

Location

Praxisgemeinschaft Dr. Hancken und Partner

Stade, 21680, Germany

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Bile Duct Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Jan Stoehlmacher, PD Dr.

  University Hospital Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: June 30, 2010
• Study Start: April 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 30, 2010

Record last verified: 2010-04

Locations

DE (8)