Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003666

Trial Description

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Title

Randomized, Open, Multicenter Phase III Study With Capecitabine Plus Bevacizumab Versus Capecitabine Plus Irinotecan Plus Bevacizumab as First-line Therapy in Patients With Metastatic Colorectal Cancer

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patient with multiple metastases, not eligible for surgery, might not profit from intensive
chemotherapy regimens. Therefore less intensive regimens focusing on survival and disease
control may be a better choice for first line treatment. Therefore this study investigates
the combination of capecitabine and bevacizumab versus the combination of capecitabine,
bevacizumab and irinotecan. In case of progressive disease, the therapy in patients treated
with capecitabine and bevacizumab is intensified by adding irinotecan. Primary endpoint is
time-of-failure strategy (TFS) comparing both treatment arms.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003666
  •   2012/05/03
  •   2010/11/29
  •   yes
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Secondary IDs

  •   2009-013099-38 
  •   NCT01249638  (ClinicalTrials.gov)
  •   ML22011  (Ludwig-Maximilians - University of Munich)
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Health Condition or Problem studied

  •   Colorectal Cancer Metastatic
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Drug: Capecitabine
  •   Drug: Bevacizumab
  •   Drug: Capecitabine
  •   Drug: Irinotecan
  •   Drug: Bevacizumab
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   III
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Primary Outcome

- TFS; time frame: 9 months; Time of Failure Strategy

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Secondary Outcome

- ORR, OS, Quality of Life, PFS-1; time frame: 36 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/12/31
  •   516
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Histologically confirmed adenocarcinoma of the colon or rectum.

- Stage IV disease.

- ECOG 0-1.

- Patients considered suitable for application of chemotherapy.

- Age 18 - 75 years.

- In- or outpatient treatment.

- Estimated life expectancy > 3 months.

- Measurable index lesion according to RECIST criteria. Evaluation of tumor
manifestations ≤ 2 weeks prior to treatment start.

- Effective contraception.

- Adequate hematologic function: leukocytes >= 3000/µl, neutrophils >= 1500/µl,
platelets >= 100.000/µ, and hemoglobin >= 9g/dl. Bilirubin <= 1,5x upper limit of
normal (ULN). ALAT and ASAT <= 2,5x ULN, in case of liver metastases <= 5x ULN. Serum
creatinine <= 1,5x ULN.

- No operations within 4 weeks prior to treatment start. No cytologic biopsies within 1
week prior to treatment start. Operation sequels need to be completely healed. Major
operations must not be expected at time of study begin, except for potential
secondary resection of liver metastases. In case of secondary resection of liver
metastases, bevacizumab must be discontinued 6-8 weeks prior to surgery.

- No relevant toxicities due to prior medical treatment at time of study entry.

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Exclusion Criteria

- primary resectable metastases

- heart failure Grade III/IV (NYHA-classification)

- Prior treatment directed against the epidermal growth factor receptor (EGFR).

- Prior treatment with bevacizumab.

- Prior chemotherapy for colorectal cancer, except for adjuvant chemotherapy dating
back > 6 months prior to study entry.

- Experimental medical treatment within 30 days prior to study entry.

- Known hypersensitivity reaction to any study medication.

- Pregnant or breast feeding women (pregnancy needs to be excluded by testing of
beta-HCG).

- Known or suspected cerebral metastases.

- Clinically significant coronary heart disease, myocardial infarction within the last
12 months or high risk of uncontrolled arrhythmia.

- Acute or subacute ileus, chronic inflammatory bowel disease or chronic diarrhea.

- Abdominal or tracheo-esophageal fistulas, gastrointestinal perforation within 6
months before study entry

- Symptomatic peritoneal carcinosis.

- Severe chronic wounds, ulcera or bone fracture.

- Uncontrolled hypertension.

- Severe proteinuria (nephrotic syndrome).

- Arterial thromboembolic events or hemorrhage within 6 months prior to study entry
(except tumor bleeding surgically treated by tumor resection).

- Bleeding diatheses or coagulopathy.

- Full dose anticoagulation.

- Known DPD-deficiency (special screening not required).

- Known glucuronidation-deficiency (special screening not required).

- Contraindication with irinotecan

- Medical history of other malignant disease within 5 years prior to study entry,
except for basalioma, and in-situ cervical carcinoma if treated with curative intent.

- Known alcohol or drug abuse.

- Medical or psychiatric condition which contradicts participation of study.

- Limited legal capacity.

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Addresses

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    • Ludwig-Maximilians - University of Munich
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    • University of Munich - Klinikum der Universitaet Muenchen
    • Volker Heinemann, Prof. Dr. med. 
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    • Volker Heinemann, Prof. Dr. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   92
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.