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XELOX+Bevacizumab Followed by Capecitabine+Bevacizumab+Radiotherapy as Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

Sponsor
Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials (Other)
Overall Status
Unknown status
CT.gov ID
NCT00557713
Collaborator
Hoffmann-La Roche (Industry)
44
Enrollment
1
Location
1
Arm
80
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the pathological complete response rate of addition of bevacizumab to induction therapy (xelox) and concomitant treatment (capecitabine+radiotherapy), followed by surgery.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Induction With XELOX-Bevacizumab in Locally Advanced Rectal Adenocarcinoma: Phase II Study
Study Start Date :
Feb 1, 2007
Anticipated Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

-Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14) -Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days)) -Surgery (6-8 weeks after last bevacizumab dose) -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)

Drug: bevacizumab
-Induction treatment. 4 cycles (every 3 weeks) of bevacizumab (7,5mg/kg day 1) + oxaliplatin (130mg/m2 day 1) + capecitabine (1000mg/m2/12h days 1-14) -Concomitant (CT+RT) treatment (3 weeks later): bevacizumab (5mg/kg day 1 of 1st, 3th and 5th weeks) + capecitabine (825mg/m2/12h daily during radiotherapy treatment) + radiotherapy (45Gy (25fractions of 1,8Gy/day over 5weeks) followed by boost 5.4Gy (1,8Gy/day over 3days)) -Surgery (6-8 weeks after last bevacizumab dose) -Adjuvant treatment: It will be individual decision of each investigator, but it's recommended 4 cycles of XELOX (equal dose at induction treatment)
Other Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pathologic Complete Response Rate [after concomitant CT-RT treatment]

    Secondary Outcome Measures

    1. Complete Resection (R0) Rate [after surgery]

    2. Disease Free Survival [from complete response to relapse or disease-related death]

    3. Time to Failure Treatment [from first treatment dose to drop out of the study]

    4. Metastatic or Local Recurrence [during study]

    5. Toxicity Evaluation [during study]

    6. Surgical Morbility [during surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Written informed consent from patients who are able to understand the study request

    • Histologically confirmed diagnosis of locally advanced rectal adenocarcinoma; ≤12 cm from the anal margin; T3, operable T4 or TxN+

    • Karnofsky PS Index ≥ 70%

    • Life expectancy > 6 months

    • Adequate bone marrow, liver and renal function: ANC ≥ 1.5 x 10e9/l; Platelets ≥ 100 x 10e9/l; Hb ≥ 9g/dl; INR ≤ 1.5; Bilirubin ≤ 1.5 x ULN; ALT and/or AST ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis); Alkaline phosphatase ≤ 2.5 x ULN or ≤ 5 x ULN (in case of hepatic metastasis) or ≤ 10 x ULN (in case of bone metastasis); Creatinine clearance (Cockcroft-Gault) ≥ 30 ml/min or seric creatinine ≤ 1.5 x ULN

    Exclusion Criteria:

    • Distant metastases; previous neoplasm during last 5 years or previous infiltrating neoplasm; previous treatment with radiotherapy or study drugs; recruited for other clinical trial in 4 weeks before study entry

    • Surgery, open biopsy or traumatic injury in 4 weeks before study entry; fine-needle aspiration in 7 days before study entry; major surgery planned during study

    • Previous heart disease or uncontrolled hypertension, previous hemorrhagic diathesis or coagulopathy; full-dose oral or parenteral anticoagulant or thrombolytic agent (low-dose warfarin is allowed, INR ≤ 1.5); chronic use of high-dose aspirin (<325mg/day) or non-steroidal anti-inflammatory treatment

    • No integrity of the upper gastrointestinal tract, malabsorption syndrome or unable to take oral drugs

    • Pregnant or lactating patients; SNC disease; allogeneic transplant with immunosuppressive drugs; bone fracture not healed, wound or severe ulcers; uncontrolled intercurrent severe infections; previous related-fluoropyrimide SAEs or DPD deficiency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ACROSS Barcelona Spain 08021

    Sponsors and Collaborators

    • Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials
    • Hoffmann-La Roche

    Investigators

    • Study Chair: Miquel Nogué, MD, Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00557713
    Other Study ID Numbers:
    • AVACROSS
    First Posted:
    Nov 14, 2007
    Last Update Posted:
    Nov 14, 2007
    Last Verified:
    Nov 1, 2007
    Additional relevant MeSH terms:
    Adenocarcinoma
    Rectal Neoplasms
    Bevacizumab

    Study Results

    No Results Posted as of Nov 14, 2007