LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
Condition: Ovarian Neoplasms; Peritoneal Neoplasms
MeSH terms: Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms
Intervention: Placebo; Paclitaxel; BIBF 1120; Carboplatin; Paclitaxel; Carboplatin
Intervention description: comparator to BIBF 1120; Paclitaxel (standard chemo-therapy); comparison of BIBF 1120 in combination with chemotherapy and placebo in combination with chemotherapy (paclitaxel/carboplatin); Carboplatin (standard chemo-therapy); Paclitaxel (standard chemo-therapy); Carboplatin (standard chemo-therapy)
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Nintedanib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1366.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and
      carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in
      first-line treatment of patients with advanced ovarian cancer. Safety information about
      BIBF1120/paclitaxel/carboplatin will be obtained.
    

Eligibility criteria:

        Inclusion criteria:

          -  first diagnosis of histologically confirmed epithelial ovarian cancer, fallopian tube
             or primary peritoneal cancer

          -  International Federation of Gynecology and Obstetrics (FIGO) Stages IIB - IV

          -  females, age 18 years or older

          -  life expectancy of at least 6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

          -  prior surgery, defined as either (a) debulking surgery with maximum surgical effort at
             cytoreduction with the goal of no residual disease or (b) biopsy or limited surgery in
             patients with stage IV disease for whom surgical debulking was not considered
             appropriate, if diagnosis is confirmed by histology and no surgery is planned prior to
             disease progression (including interval debulking surgery)

          -  patient has given written informed consent which must be consistent with the
             International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and local
             legislation

          -  planned application of first dose of chemotherapy after wound healing, but no later
             than 10 weeks after surgery

        Exclusion criteria:

          -  histologic diagnosis of a benign or borderline tumour or of a malignant tumour of
             non-epithelial origin of the ovary, the fallopian tube or the peritoneum

          -  planned surgery within 124 weeks after randomisation in this trial, including interval
             debulking surgery

          -  clinically relevant non-healing wound, ulcer or bone fracture

          -  clinical symptoms or signs of gastrointestinal obstruction that require parenteral
             nutrition or hydration

          -  brain metastases

          -  pre-existing sensory or motor neuropathy Common Terminology Criteria for Adverse
             Events (CTCAE) grade 2 or higher, except due to trauma

          -  history of major thromboembolic event

          -  known inherited or acquired bleeding disorder

          -  significant cardiovascular diseases

          -  clinically relevant pericardial effusion

          -  history of a cerebral vascular accident, transient ischemic attack or subarachnoid
             haemorrhage within the past 6 months

          -  inadequate safety laboratory values

          -  serious infections in particular if requiring systemic antibiotic (antimicrobial,
             antifungal) or antiviral therapy, including Hepatitis B, Hepatitis C, Human
             Immunodeficiency Virus (HIV)

          -  poorly controlled diabetes mellitus or other contraindication to high dose
             corticosteroid therapy

          -  gastrointestinal disorders or abnormalities that would interfere with absorption of
             the study drug

          -  other malignancy diagnosed within the past 5 years. In exception to this rule, the
             following malignancies may be included if adequately treated: non-melanomatous skin
             cancer, cervical carcinoma in situ, carcinoma in situ of the breast, low risk
             endometrial cancer

          -  prior systemic therapy for ovarian cancer (e.g. chemotherapy, monoclonal antibody
             therapy, oral targeted therapy, hormonal therapy)

          -  prior systemic cytotoxic chemotherapy

          -  prior treatment with BIBF 1120 or any other angiogenesis inhibitor

          -  prior radiotherapy

          -  serious illness or concomitant non-oncological disease such as neurologic, psychiatric
             or infectious disease or a laboratory abnormality that may increase the risk
             associated with study participation or study drug administration

          -  Women of childbearing potential who are sexually active and not using a highly
             effective method of birth control during the trial and for at least twelve months
             after the end of active therapy.

          -  pregnancy or breast feeding

          -  psychological, familial, sociological or geographical factors potentially hampering
             compliance with the study protocol and follow-up schedule

          -  active alcohol or drug abuse

          -  patients unable to comply with the protocol

          -  any contraindications for therapy with paclitaxel or carboplatin

          -  treatment with other investigational drugs or participation in another clinical trial
             testing a drug within the past four weeks before start of therapy or concomitantly
             with this trial