Preoperative Combined RadioChemo-Molecular Target Therapy With Capecitabine, Bevacizumab, and Radiotherapy

This study has been terminated.
(reaching of step 1 (recruitment of 8 patients) per protocol -> risk assessment -> termination because of occurance of toxicity Grade 3 and 4)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00671645
First received: April 30, 2008
Last updated: March 12, 2009
Last verified: March 2009
  Purpose
  • feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma
  • collection of response rate (T- and M-downstaging, pathological complete remission)

Condition Intervention Phase
Rectal Cancer
Drug: capecitabine, bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Combined RadioChemo-MolecularTargetTherapy of the Locally Advanced Rectum Carcinoma (cT3NxM0) - a Phase II Pilot Study With Preoperative Application of Capecitabine, Bevacizumab and Radiotherapy (RTx)

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • feasibility and tolerance of preoperative therapy with Bevacizumab in combination with Capecitabine and radiotherapy for patients with locally advanced, locally operable rectal carcinoma [ Time Frame: descriptive evaluation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • collection of response rate (T- and M-downstaging, pathological complete remission) [ Time Frame: descriptive evaluation ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine, bevacizumab
Capecitabine 825 mg/m2 bid (on each therapy day of first 4 Therapy weeks) Bevacizumab 5 mg/kg weight; day 1, 15, 29
Other Names:
  • Xeloda
  • Avastin

Detailed Description:

Combined RadioChemotherapy:

Therapy start: within 28 days after bioptical diagnosis

Radiotherapy: 5 x 5 days 1.8 Gy radiotherapy; cummulative dose 45 Gy

Chemotherapy: Capecitabin 825mg/m² bid, on each radiation day during the first 4 weeks RCTx

Molecular Targeted Therapy: Bevacizumab 5 mg/kg body weight; day 1, 15, 29 Operation due to TME adherence to a break of min. 42 to max. 56 days after the last application of bevacizumab

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age: 18 - 80
  • bioptical confirmed adenocarcinoma of the rectum in T3NxM0 status. The tumor has to be basically surgically complete resectable (->R0).
  • no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of rectum carcinoma
  • WHO performance status 0-2
  • adequate bone marrow reserve (granulocytes >= 3.000/µl, absolute neutrophil >= 0 1,5 x 10 9/l thrombocytes: >= 100.000/µl, haemoglobin >= 10g/dl)
  • adequate hepatic function (Bilirubin: <= 1.5 x ULN, GOT und GPT <= 2.5 x ULN)
  • adequate renal function (creatinin: <= 1.25 mg/dl, creatinin-clearance: > 50 ml/min (Cockcroft and Gault formula)), proteinuria: dipstick < 2+. In case of dipstick > 2+ protein has to be measured in 24h urine and does not exceed more than 1g/24h)
  • ability of intake of pills
  • women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
  • willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study
  • life expectancy of at least 3 month
  • INR and aPTT < 1.5 ULN
  • signed Informed Consent before recruitment

Exclusion Criteria:

  • failure of one inclusion criteria
  • former radiotherapy of pelvis or abdomen
  • former chemotherapy
  • any other kind of malign tumor in the last 5 years
  • any other kind of tumour in the last 5 years with exception of basal cell carcinoma of skin and cervix carcinoma in situ
  • general contraindication or known hypersensitivity against Bevacizumab and/or Capecitabine
  • non malign disease, if there is a contraindication with radiotherapy, or chemotherapy with Bevacizumab and Capecitabine, or a resection of rectum: uncontrolled hypertension (systolic > 150 mmHG and/or diastolic >100 mmHG) or clinical significant (e.g. active) cardiovascular disease: CVA (cardiovascular accident)/ cerebral apoplexy (< 6 months before recruitment), myocardial infarct (< 6 months before recruitment), instable angina pectoris, CHF with NYHA status II or higher, or treated serious arrhythmia, hepatic disease, significant neurologic or psychiatric disorders
  • florid, serious infections at the time of recruitment
  • peripheral neuropathy (NCI CTC >= Grade 1)
  • legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator
  • evidence of lacking cooperation of the patient
  • major intervention within 28 days before recruitment, open wounds
  • serious injuries, unhealed wounds or fractures
  • patients with spinal compressions or metastases in central nervous system
  • evidence of bleeding diathesis or coagulation dysfunction
  • actual intake of anticoagulant or thrombolytic agents, Aspirin > 325 mg/d or within 10 days before study start)
  • actual or recent (within 10 days before recruitment) therapeutic therapy with fully-dosed anticoagulants. A prophylactic treatment is permitted.
  • previous thromboembolic or hemorrhagic events within the last 6 months before recruitment
  • previous abdominal fistulas, GI perforation or intra-abdominal abscess within the last 6 months
  • treatment with other study medication within 28 days before recruitment
  • patients with malabsorption syndrome or difficulties swallowing
  • pregnant or breast feeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671645

Locations
Austria
Hospital BHB St. Veit/Glan, Surgery
St. Veit/Glan, Carinthia, Austria, 9300
Medical University Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben, Surgery
Leoben, Styria, Austria, 8700
Medical University Innsbruck, Internal Medicine
Innsbruck, Tyrol, Austria, 6020
Hospital BHS Linz, Radiooncology
Linz, Upper Austria, Austria, 4010
Klinikum Wels-Grieskirchen, Coop. Group
Wels, Upper Austria, Austria, 4600
State Hospital Feldkirch, Radiotherapy
Feldkirch, Vorarlberg, Austria, 6807
State Hospital Salzburg-Paracelsius Medical University - Oncology
Salzburg, Austria, 5020
Medical University Vienna, Radiotherapy
Vienna, Austria, 1090
Hospital BHB Vienna, Surgery
Vienna, Austria, 1020
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Hoffmann-La Roche
Investigators
Principal Investigator: Dietmar Oefner, MD, MSc Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Alexander de Vries, MD Austrian Breast & Colorectal Cancer Study Group
Principal Investigator: Wolfgang Eisterer, MD ABCSG, TAKO
  More Information

Additional Information:
No publications provided

Responsible Party: Hannes Fohler , Trial Office Director, ABCSG
ClinicalTrials.gov Identifier: NCT00671645     History of Changes
Other Study ID Numbers: ABCSG R04/TAKO 08
Study First Received: April 30, 2008
Last Updated: March 12, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
pilot study
rectal
carcinoma
phase II
preoperative
RadioChemo
molecular
target
therapy
T3
ABCSG
TAKO
R04
08

Additional relevant MeSH terms:
Capecitabine
Fluorouracil
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014