A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Trifluridine/tipiracil + bevacizumab; Capecitabine + bevacizumab
Intervention description: Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.; Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
Intervention MeSH terms: Trifluridine; Bevacizumab; Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; colorectal; cancer; untreated; first-line; S95005 (Trifluridine/tipiracil); bevacizumab; capecitabine

Summary:

      The main purpose of this study is to evaluate the progression-free survival (PFS) in patients
      receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control
      arm) as first-line treatment for unresectable metastatic colorectal cancer in patients
      non-eligible for intensive therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained.

          -  Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the
             time of the randomisation.

          -  Has definitive histologically or cytologically confirmed adenocarcinoma of the colon
             or rectum.

          -  RAS status must have been determined (mutant or wild).

          -  Has at least one measurable metastatic lesion.

          -  No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.

          -  Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is
             allowed only if if it has been completed more than 6 months before start of study
             treatment.

          -  Patient is not a candidate for combination chemotherapy with irinotecan or
             oxaliplatin, or for curative resection of metastatic lesions.

          -  Is able to take medication orally (i.e., no feeding tube).

          -  Has adequate organ function.

          -  Coagulation parameters in normal limit (or in therapeutic limit for patients treated
             with anticoagulant drugs).

          -  Women of childbearing potential must have been tested negative in a serum pregnancy
             test. Female participants of childbearing potential and male participants with
             partners of childbearing potential must agree to use a highly effective method of
             birth control. Women and female partners using hormonal contraceptive must also use a
             barrier method.

        Exclusion Criteria:

          -  Is a pregnant or lactating female.

          -  Has certain serious illness or serious medical condition(s) as described in the
             protocol.

          -  Has had certain other recent treatment e.g. major surgery, field radiation, received
             investigational agent, within the specified time frames prior to randomisation.

          -  Has previously received Trifluridine/tipiracil or history of allergic reactions
             attributed to compounds of similar composition to Trifluridine/tipiracil or any of its
             excipients.

          -  Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
             glucose-galactose malabsorption.

          -  Has contra-indication to bevacizumab or capecitabine.