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Colorectal NeoplasmsPhase 2FOSCONCT00889343

Study to Evaluate the Effects of Sorafenib if Combined With Chemotherapy (FOLFOX6 or FOLFIRI) in the Second-Line Treatment of Colorectal Cancer

A Phase 2 study testing Sorafenib, Oxaliplatin or Irinotecan and Leucovorin in people with Colorectal Neoplasms, run by AIO-Studien-gGmbH at 57 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether sorafenib in combination with chemotherapy has a positive effect on time to progression of the tumor or death for the treatment of large bowel cancer that has already progressed during a first chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Sorafenib, Oxaliplatin or Irinotecan and Leucovorin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
57 sitesGermany
Study dates
Mar 2009to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 years.
  • ECOG Performance Status of 0 to 2
  • Life expectancy of at least 12 weeks.
  • Subjects with at least one uni-dimensional (RECIST) measurable lesion of metastatic colorectal carcinoma after first-line chemotherapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently. Lesions must be measured by CT-scan or MRI.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
  • Hemoglobin > 9.0 g/dl
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  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count 100,000/μl Total bilirubin < 1.5 times the upper limit of normal
  • ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer)
  • Alkaline phosphatase < 4 x upper limit of normal
  • PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
  • Serum creatinine < 1.5 x upper limit of normal
  • Signed and dated informed consent before the start of specific protocol procedures

Who cannot join

  • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
  • History of HIV infection or chronic hepatitis B or C
  • Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
  • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • History of organ allograft
Show all 24Show fewer
  • Patients with evidence or history of bleeding diathesis
  • Patients undergoing renal dialysis
  • Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
  • Contraindications for the use of atropine in patients receiving FOLFIRI
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry.
  • Peripheral sensory neuropathy > CTC grade 2
  • Chronic inflammatory bowel disease; ileus; genetic fructose intolerance
  • Pregnant or breast-feeding patients.
  • Women of childbearing potential must have a negative pregnancy test performed within 7 days before the start of treatment. Fertile women and men (<2 years after last menstruation in women) must use effective means of contraception (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during treatment and for at least 6 months after last administration of medication.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient"s participation in the study or evaluation of the study results
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 18. Patients unable to swallow oral medications.
  • Any other anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry.
  • Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed). Major surgery within 4 weeks of start of study
  • Autologous bone marrow transplant or stem cell rescue within 4 months prior to study treatment
  • Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however, they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study]
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
  • Prior exposure to the study drug.
  • Any St. John´s wort containing remedy

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

Germany57 sites

  • Ostalb-Klinikum Aalen, Medizinische Klinik 1

    Aalen, Baden-Wurttemberg, 73428

  • Medizinische Universitätsklinik-Knappschaftskrankenhaus, Medizinische Klinik

    Bochum, North Rhine-Westphalia, 44892

  • DIAKO Ev. Diakonie-Krankenhaus gGmbH, Medizinische Klinik II

    Bremen, Free Hanseatic City of Bremen, 28239

  • Gemeinschaftspraxis für Hämatologie und Onkologie am Sachsenring

    Cologne, North Rhine-Westphalia, 50677

  • Klinikum Darmstadt, Medizinische Klinik V

    Darmstadt, Hesse, 64283

  • St. Vincenz-Krankenhaus, Medizinische Klinik I

    Datteln, North Rhine-Westphalia, 45711

  • Städtisches Klinikum Dessau, Klinik für Innere Medizin

    Dessau, Saxony-Anhalt, 06847

  • Praxisgemeinschaft Dr. med. Thomas Göhler und Steffen Dörfel

    Dresden, Saxony, 01127

  • St. Antonius Hospital, Klinik für Hämatologie / Onkologie

    Eschweiler, North Rhine-Westphalia, 52249

  • Hämato-Onkologisches Gemeinschaftspraxis

    Essen, North Rhine-Westphalia, 45136

  • Städtische Kliniken Frankfurt a.M. - Höchst, Klinik für Innere Medizin Abt. 3

    Frankfurt a.M., Hesse, 65929

  • Vitanus GmbH

    Frankfurt am Main, Hesse, 60596

  • Klinikum Fulda, Tumorklinik

    Fulda, Hesse, 36043

  • Überörtliche Gemeinschaftspraxis Dres. Wilke und Wagner

    Fürth, Bavaria, 90766

  • Katholisches Krankenhaus Hagen gem. GmbH, Klinik für Hämatologie und Onkologie

    Hagen, North Rhine-Westphalia, 58095

  • Onkologische Gemeinschaftspraxis

    Halle, Saxony-Anhalt, 06110

  • MVZ für Innere Medizin in Hamburg Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20248

  • MediProjekt, Gesellschaft für Medizinstatistik und Projektentwicklung

    Hanover, Lower Saxony, 30171

  • Krankenhaus Siloah, Medizinische Klinik III

    Hanover, Lower Saxony, 30449

  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie, Endokrinologie

    Hanover, Lower Saxony, 30625

  • Hämatologischonkologische Schwerpunktpraxis

    Herrsching am Ammersee, Bavaria, 82211

  • Onkologische Schwerpunktpraxis Hildesheim

    Hildesheim, Lower Saxony, 31135

  • Universitätskliniken des Saarlandes, Innere Medizin I

    Homburg / Saar, Saarland, 66421

  • eps-early phase solution GmbH

    Jena, Thuringia, 07743

  • Onkologische Praxisgemeinschaft Dres. Siehl, Söling und Prof. Hirschmann

    Kassel, Hesse, 34117

  • Hämatologie Onkologie Tagesklinik Landshut

    Landshut, Bavaria, 84028

  • Hämatologie u. Internistische Onkologie

    Lehrte, Lower Saxony, 31275

  • Klinikum Leverkusen gGmbH, Medizinische Klinik III

    Leverkusen, North Rhine-Westphalia, 51375

  • Gemeinschaftspraxis für Hämatologie und Internistische Onkologie

    Magdeburg, Saxony-Anhalt, 39104

  • I. Medizinische Klinik und Poliklinik der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Philipps-Universität, Klinikum Marburg, Klinik für Innere Medizin mit SP Hämatologie und Onkologie

    Marburg, Hesse, 35043

  • Hämato-Onkologische Schwerpunktpraxis Prof. Salat / Dr. Stoetzer / Prof. Hiller

    München, Bavaria, 80639

  • Gemeinschaftspraxis Hämatologie und Onkologie

    Münster, North Rhine-Westphalia, 48149

  • Friedrich-Ebert-Krankenhaus Neumünster, Klinik für Hämatologie, Onkologie und Nephrologie

    Neumünster, Schleswig-Holstein, 24534

  • Hämatologisch-onkologische Praxis Dr. med. Peter Schmidt

    Neunkirchen, Saarland, 66821

  • Internistische Praxis & Tagesklinik

    Neutstadt/Sachsen, Saxony, 01844

  • Hämatologisch-onkologische Schwerpunktpraxis Northeim

    Northeim, Lower Saxony, 37154

  • Kreiskliniken Esslingen gGmbH, Klinik Nürtingen, Medizinische Klinik I

    Nürtingen, Baden-Wurttemberg, 72622

  • Gemeinschaftspraxis für Hämatologie und Internistische Onkologie

    Offenbach, Hesse, 63065

  • Niels-Stensen-Kliniken, Marienhospital Osnabrück GmbH,

    Osnabrück, Lower Saxony, 49074

  • Medizinisches Versorgungszentrum am Siloah St. Trudpert Klinikum

    Pforzheim, Baden-Würtemberg, 75179

  • Gemeinschaftspraxis Onkologie Ravensburg

    Ravensburg, Baden-Wurttemberg, 88214

  • Praxis und Tagesklinik für Internistische Onkologie und Hämatologie

    Recklinghausen, North Rhine-Westphalia, 45657

  • Prosperhospital Recklinghausen, Medizinische Klinik I

    Recklinghausen, North Rhine-Westphalia, 45659

  • Universitätsklinikum Rostock, Klinik für Innere Medizin

    Rostock, Mecklenburg-Vorpommern, 18057

  • Wissenschaftskontor Nord GmbH und Co KG

    Rostock, Mecklenburg-Vorpommern, 18107

  • Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, I. Chirurgische Klinik

    Rotenburg (Wümme), Lower Saxony, 27356

  • Leopoldina-Krankenhaus, Medizinische Klinik II

    Schweinfurt, Bavaria, 97422

  • Gemeinschaftspraxis Dr. med. U. Banhardt, Dr. med. T. Fietz

    Singen, Baden-Wurttemberg, 78224

  • Praxisgemeinschaft Dr. Hancken und Partner, Onkologische Schwerpunktpraxis

    Stade, Lower Saxony, 21680

  • Klinikum Mutterhaus der Borromäerinnen gGmbH, Innere Medizin I

    Trier, Rhineland-Palatinate, 54290

  • Kreiskliniken Traunstein -Trostberg GmbH , Innere Medizin/ Hämatologie und Onkologie

    Trostberg an der Alz, Bavaria, 83308

  • Universitätsklinikum Ulm, Zentrum für Innere Medizin, Klinik für Innere Medizin I

    Ulm, Baden-Wurttemberg, 89070

  • Sophien- und Hufeland-Klinikum gGmbH, Klinik für Innere Medizin II

    Weimar, Thuringia, 99425

  • Lahn-Dill-Kliniken GmbH, Darmzentrum

    Wetzlar, Hesse, 35578

  • Internistische Gemeinschaftspraxis

    Witten, North Rhine-Westphalia, 58452

  • HELIOS Klinikum Wuppertal , Medizinische Klinik I

    Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

About this study

Official title: A Controlled Randomized Double-blind Multi-center Phase II Study of FOLFOX6 or FOLFIRI Combined With Sorafenib Versus Placebo in Second-line Metastatic Colorectal Carcinoma

The purpose of this study is to determine whether sorafenib in combination with chemotherapy has a positive effect on time to progression of the tumor or death for the treatment of large bowel cancer that has already progressed during a first chemotherapy.

Read the detailed description

Patients with metastatic CRC who received a first-line therapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently, are eligible for this study. Patients will be randomized to receive chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib 400 mg bid or chemotherapy + placebo. Patients who have received an Oxaliplatin based Fluoropyrimidine containing regimen in first-line will obtain FOLFIRI during this study. Patients who have received an Irinotecan based Fluoropyrimidine containing regimen in first-line will obtain FOLFOX6.

Primary objective of the study is to compare the Progression-free-survival (PFS) between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo.

Being tested
Sorafenib, Placebo, Oxaliplatin or Irinotecan, Leucovorin, 5-Fluorouracil
Keywords
Second-line therapy of metastatic colorectal cancer, Sorafenib, Colorectal Neoplasms, palliative therapy, after progression of firstline therapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Also called Nexavar

    2x200 mg filmcoated tablets BID on day 2-12 of a 14-days cycle, oral

  • PlaceboDrug

    2 filmcoated tablets BID, day 2-12 of a 14-days cycle, oral

  • Oxaliplatin or IrinotecanDrug

    Oxaliplatin 100 mg/m2 intravenous infusion on day 1 of 14-days cycle, Irinotecan 180 mg/m2 intravenous infusion on day 1 of 14-days cycle

  • LeucovorinDrug

    400 mg/m2 intravenous infusion on day 1 of a 14-days cycle

  • 5-FluorouracilDrug

    400 mg/m2 intravenous bolus infusion on day 1, 2400 mg/m2 46 hour intravenous infusion on day 1 to 2 of a 14-days cycle

Study groups in NCT00889343
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Sorafenib; Drug: Oxaliplatin or Irinotecan; Drug: Leucovorin; Drug: 5-Fluorouracil
2Placebo comparatorNot described
Receives: Drug: Placebo; Drug: Oxaliplatin or Irinotecan; Drug: Leucovorin; Drug: 5-Fluorouracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the PFS between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo

    Measured: 6 to 12 months

Secondary outcomes (4)

  1. Disease control rate

    Measured: 6 to 12 months

  2. Overall survival

    Measured: 6 to 12 months

  3. Response rates

    Measured: 6 to 12 months

  4. Safety

    Measured: signature of informed consent until 30 days after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2011
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00889343
Sponsor's protocol ID
AIO KRK 0307
Acronym
FOSCO
Status last verified
Mar 2013
First submitted
17 Apr 2009
Last updated
4 Mar 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sorafenib, Oxaliplatin or Irinotecan and Leucovorin in people with Colorectal Neoplasms, run by AIO-Studien-gGmbH at 57 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the PFS between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo (time frame: 6 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00889343.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2013.

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FOSCO Clinical Trial NCT00889343 | AzTrials