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TRICC-C (AIO-KRK-0111): BIBF 1120 Versus Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC) (AIO-KRK-0111)

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ClinicalTrials.gov Identifier: NCT01362361
Recruitment Status : Unknown
Verified April 2012 by Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was:  Recruiting
First Posted : May 30, 2011
Last Update Posted : April 6, 2012
Sponsor:
Collaborator:
GALMED GmbH, Halle, Germany
Information provided by (Responsible Party):
Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg

Brief Summary:

The purpose of this study:

To explore the comparative effectiveness of BIBF 1120 in terms of :

  • Progression-free survival (PFS), objective response, overall survival
  • Evaluate and compare safety

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: mFOLFOX6 + BIBF 1120 Drug: mFOLFOX6+placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: TRICC-C: A Multicenter, Randomized, Phase II Trial: BIBF 1120 vs. Placebo in Patients Receiving Oxaliplatin Plus Fluorouracil and Leucovorin (mFOLFOX6) for Advanced, Chemorefractory Metastatic Colorectal Cancer (mCRC)
Study Start Date : June 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
mFOLFOX6 + BIBF 1120
Drug: mFOLFOX6 + BIBF 1120
mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days)

Placebo Comparator: Arm B
mFOLFOX6+placebo
Drug: mFOLFOX6+placebo
mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days)




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven colorectal adenocarcinoma
  2. Intended treatment with mFOLFOX6 after one prior palliative chemotherapy for metastatic CRC
  3. Age > 18 years
  4. Metastatic disease not suitable for curative-intent surgery
  5. Measurable (> 1 cm) and evaluable disease (according to RECIST 1.1 criteria)
  6. Prior bevacizumab, cetuximab or panitumumab are allowed.
  7. Previous adjuvant oxaliplatin-containing therapy is allowed, if the end of adjuvant chemotherapy is >12 months prior to inclusion into the trial
  8. ECOG performance status 0 or 1 (see appendix 10.4)
  9. Adequate hepatic function
  10. Adequate Renal function
  11. Adequate bone marrow function
  12. Other lab parameters: proteinuria < CTCAE grade 2, Prothrombin time and/or partial thromboplastin time < 50 % deviation from normal limits
  13. Life expectancy at least 3 months
  14. Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation

Exclusion Criteria:

  1. Known hypersensitivity to the trial drugs or their excipients.
  2. Treatment with any investigational drug within 28 days of trial onset.
  3. Prior treatment with more than one line of palliative standard chemotherapy for colorectal cancer, prior treatment with a tyrosine kinase inhibitor, prior palliative treatment with an oxaliplatin-containing regime.
  4. History of other malignancies in the last 5 years, in particular those which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
  5. Serious concomitant disease, especially those that would limit compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration, and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
  6. Major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period. Portimplantation prior to therapy is allowed.
  7. Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II) (see appendix 10.3).
  8. History of severe haemorrhagic or thrombotic events in the past 12 months (excluding central venous catheter thrombosis and peripheral deep vein thrombosis). Known inherited predisposition to bleeds or to thrombosis.
  9. Patient with brain metastases that are symptomatic and/or require therapy.
  10. Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid ≤ 325mg per day)
  11. History of major thrombotic or clinically relevant major bleeding event in the past 6 months
  12. Current peripheral neuropathy ≥ CTCAE grade 2 except due to trauma
  13. Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy
  14. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
  15. Active alcohol or drug abuse.
  16. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  17. Pregnancy or breast-feeding
  18. Leptomeningeal disease
  19. Radiographic evidence of cavitary or necrotic tumours
  20. Centrally located tumours with radiographic evidence (CT or MRI) of local invasion of major blood vessels
  21. Severe chemotherapy-associated toxicity during or after adjuvant or palliative first-line chemotherapy like 5-FU-associated cardiac toxicity (coronary spasm) or persistent oxaliplatin-associated peripheral neuropathy (≥ CTCAE grade 2) with paresthesia associated with pain or functional impairment (after adjuvant oxaliplatin-containing chemotherapy).

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362361


Contacts
Contact: Thomas Seufferlein, MD +49-345-557-2661 thomas.seufferlein@uk-halle.de

Locations
Germany
Universitätsklinikum Halle Recruiting
Halle, Sachsen-Anhalt, Germany, 06120
Contact: Thomas Seufferlein, MD         
Principal Investigator: Thomas Seufferlein, MD         
Sub-Investigator: Thomas J. Ettrich, MD         
Schwerpunktpraxis für Hämatologie und Onkologie Bottrop und Dorsten Recruiting
Bottrop, Germany
Principal Investigator: Carla V. Hannig, MD         
Universitätsklinikum Greifswald -Klinik für Innere Medizin A Recruiting
Greifswald, Germany
Principal Investigator: Julia Mayerle, MD         
Gemeinschaftspraxis und Tagesklinik Onkologie und Gastroenterologie - Halle Recruiting
Halle, Germany
Principal Investigator: Stefanie Frank-Gleich, MD         
Klinikum Karlsruhe, Medizinische Klinik III Recruiting
Karlsruhe, Germany
Principal Investigator: Margarethe Schmier, MD         
Kliniken der Stadt Köln gGmbH - Krankenhaus Holweide Recruiting
Köln, Germany
Principal Investigator: Claudia Lang, MD         
Universitätsmedizin Mannheim - TTZ am Interdisziplinären Tumorzentrum Recruiting
Mannheim, Germany
Principal Investigator: Ralf Hofheinz, MD         
Joh. Wesling Klinikum Minden Recruiting
Minden, Germany
Principal Investigator: Hans-Joachim Tischler, MD         
Stauferklinikum Schwäbisch Gmünd - Mutlangen - Zentrum Innere Medizin Recruiting
Mutlangen, Germany
Principal Investigator: Holger Hebart, MD         
Klinikum der Universität München-Großhadern - Medizinische Klinik und Poliklink III Recruiting
München, Germany
Principal Investigator: Volker Heinemann, MD         
Leopoldina-Krankenhaus Schweinfurt - Medizinische Klinik 2 Recruiting
Schweinfurt, Germany
Principal Investigator: Stephan Kanzler, MD         
Universitätsklinikum Ulm - Klinik für Innere Medizin I Recruiting
Ulm, Germany
Principal Investigator: Götz von Wichert, MD         
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
GALMED GmbH, Halle, Germany

Responsible Party: Prof. Dr. med. Thomas Seufferlein, PI, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01362361     History of Changes
Other Study ID Numbers: TRICC-C (AIO-KRK-0111)
2010-023050-37 ( EudraCT Number )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Prof. Dr. med. Thomas Seufferlein, Martin-Luther-Universität Halle-Wittenberg:
Second line colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Nintedanib
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors