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Completed

NCT Number: NCT00598156

Chemotherapy and Avastin Followed by Maintenance Treatment With Avastin +/- Tarceva

Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vejle Hospital, Department of Oncology, Copenhagen, Denmark

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About this study

Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adenocarcinoma of the colon or rectum.
  • Age > 18.
  • Measurable disease according to RECIST criteria.
  • Expected survival more than three months.
  • Adequate bone marrow, liver and kidney function.
  • INR < 1.5 times upper limit.
  • Adequate contraception for fertile patients.
  • Signed written informed consent.

Exclusion criteria

  • Earlier chemotherapy for metastatic colorectal cancer.
  • Adjuvant treatment within 6 months.
  • Surgery or significant trauma within 28 days prior to study entry.
  • Planned radiotherapy against target lesions.
  • CNS metastases.
  • Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.
  • Bleeding diathesis
  • Uncontrolled hypertension.
  • Significant cardiovascular disease.
  • Treatment with anticoagulant drugs.
  • Participation in other clinical trial.
  • Pregnant or lactating.

Treatment and study plan

Erlotinib (Tarceva)

Drug

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Bevacizumab (Avastin)

Drug

Chemotherapy for 18 weeks (XELOX, XELIRI, FOLFOX or FOLFIRI)

Primary outcomes

  1. progression-free survival

    Time frame: 3 years

Secondary outcomes

  1. overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.

Acronym: ACT

Important dates

Study start
2007
Primary completion
2009
Study completion
2012
First posted
Jan 18, 2008
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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