Randomized three arm phase III trial on induction treatment with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy for 24 weeks followed by maintenance treatment with a fluoropyrimidine and bevacizumab vs. bevacizumab alone vs. no maintenance treatment and reinduction in case of progression for first-line treatment of patients with metastatic colorectal cancer - Optimal Maintenance Therapy with bevacizumab after Induction in metastatic CRC

• Conditions: Histologically confirmed and inoperable or irresectable metastatic colorectal cancer (stage IV); MedDRA version: 14.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-007974-39-DE
• Lead Sponsor: AIO-Studien-gGmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-26
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Histologically confirmed and inoperable or irresectable metastatic colorectal cancer (stage IV)

- Measurable lesion according to RECIST measured within 4 weeks prior to registration of the subject for the study

Not allowed prior treatments
- Previous chemotherapy for metastatic disease (adjuvant therapy for non-metastasized disease is allowed if terminated more than 6 months ago and without recurrence within 6 months after the end of adjuvant treatment)
- Prior radiation of indicator lesion(s), except for documented progression during radiation and termination of radiotherapy at least 4 weeks prior to entry into the study

- 18 years and over

- ECOG 0-2

- No past or current history of malignancies except for the indication under this study and curatively treated:
oBasal and squamous cell carcinoma of the skin
oIn-situ carcinoma of the cervix
oOther malignant disease without recurrence after at least 5 years of follow-up
- No severe internal disease (insufficiently treated or uncontrolled arterial hypertension, hemoptoe, NYHA grade II or greater congestive heart failure, symptomatic coronary heart disease, myocardial infarction (= 12 months prior to inclusion), serious cardiac arrhythmia requiring medication, peripheral arterial occlusive disease stage II or greater, uncontrolled severe disease)
- No history or evidence upon physical examination of CNS disease unless adequately treated
- No pre-existing neuropathy >= grade 1 (NCI CTCAE), except for loss of tendon reflex as the only symptom
- No interstitial pneumonia or symptomatic fibrosis of the lung
- No allogenic transplantation requiring immuno-suppressive therapy
- No severe non-healing wounds, ulcers or bone fractions
- No thrombosis or severe bleeding within 6 months prior to entry into the study (except for bleeding of the tumor before its surgical resection) and no evidence of bleeding diathesis or coagulopathy.
- Patients not receiving therapeutic anticoagulation must have an INR < 1.5 ULN and aPTT < 1.5 ULN within 7 days prior to registration. The use of full dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks at the time of registration.

Laboratory requirements - within 7 days prior to enrollment
- Neutrophil count >= 1,500/µl
- Platelets >= 100,000/µl
- Hb >= 9g/dl (may be transfused to maintain or exceed this level)
- Serum creatinine clearance > 50ml/min (Cockroft/Gault)
- Serum total bilirubin: =< 1.5 x ULN
- AST and ALT =< 2.5 x ULN; =< 5 x ULN in subjects with documented liver metastases

Lab requirements in fertile woman -within 2 days prior to treatment)
- Negative serum pregnancy test

Other medication
- No concomitant therapy with certain anti-viral medicines
- No continuous medication with ASS > 325 mg or NSAIDs, known to inhibit platelet function

Other
- No major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, nor anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration, which must be inserted at least 2 days prior to treatment start. With the only exception of a high remission pressure in case of synchronous metastases in just resected colorectal cancer,

Exclusion Criteria

See with E.2 Principal inclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified