Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003654

Trial Description

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Title

A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

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Trial Acronym

BOOST

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to determine whether the early and continuous addition of
bevacizumab for up to 30 months to the standard chemotherapy is more effective than the
early and continuous addition of bevacizumab for up to 15 months.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003654
  •   2012/04/30
  •   2011/10/25
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   2011-001015-32 
  •   NCT01462890  (ClinicalTrials.gov)
  •   AGO-OVAR 17  (AGO Study Group)
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Health Condition or Problem studied

  •   Genital Diseases, Female
  •   Ovarian Diseases
  •   Ovarian Neoplasms
  •   Fallopian Tube Neoplasms
  •   Peritoneal Neoplasms
  •   C56 -  Malignant neoplasm of ovary
  •   C78.6 -  Secondary malignant neoplasm of retroperitoneum and peritoneum
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Interventions/Observational Groups

  •   Biological: Bevacizumab
  •   Biological: Bevacizumab
  •   Drug: Paclitaxel
  •   Drug: Carboplatin
  •   Other: specialized pathology review (Germany only)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Progression Free Survival (PFS); time frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months

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Secondary Outcome

- Objective response rate (ORR); time frame: every 12 weeks until progression or up to 30 months, thereafter every 6 months
- Overall survival (OS); time frame: every 3 weeks, 31 months after start of treatment, thereafter every 6 months
- Health related Quality of life (QoL); time frame: baseline, then every 12 weeks until progression, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
- Safety and tolerability, i.e. type, frequency, severity and duration of adverse reactions; time frame: every 3 weeks, 31 months after start of treatment or if applicable 4 weeks after last dose of bevacizumab (whichever occurs later)
- Translational Research - Tumor Tissue Block; time frame: Assessment at end of study planned; may be obtained at any time during therapy, preferably at cycle 1 or at a subsequent visit
- Translational Research - Complementary and Alternative Treatment Questionnaires; time frame: baseline, 6 months and 12 months after start of treatment, if required at timepoint of treatment termination

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2011/11/30
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Signed written informed consent obtained prior to initiation of any study specific
procedures and treatment as confirmation of the patients awareness and willingness to
comply with the study requirements

- Primary diagnosis is confirmed by specialized pathology review (Germany only)

- Females aged ≥ 18 years

- Histologically confirmed, newly diagnosed

- Epithelial ovarian carcinoma

- Fallopian tube carcinoma

- Primary peritoneal carcinoma AND FIGO stage IIb - IV (all grades and all
histological types)

- Patients should have already undergone surgical debulking, by a surgeon experienced
in the management of ovarian cancer, with the aim of maximal surgical cytoreduction
according to the GCIG Conference Consensus Statement. There must be no planned
surgical debulking prior to disease progression. Patients with stage III and IV
disease in whom initial surgical debulking was not appropriate or possible will still
be eligible providing

- the patient has a histological diagnosis and

- debulking surgery prior to disease progression is not foreseen

- Patients must be able to commence cytotoxic chemotherapy within 8 weeks of
cytoreductive surgery. The first dose of bevacizumab can be omitted in both arms if
the investigator decides to start chemotherapy within 4 weeks of surgery.

- ECOG 0-2

- Life expectancy > 3 months

- Adequate bone marrow function (within 14 days prior to randomization)

- ANC ≥ 1.5 x 10^9/L

- PLT ≥ 100 x 10^9/L

- Hb ≥ 9 g/dL (can be post-transfusion)

- Adequate coagulation parameters (within 14 days prior to randomization)

- Patients not receiving anticoagulant medication who have an INR ≤ 1.5 and an
aPTT ≤ 1.5 x ULN

- The use of full-dose oral or par-enteral anticoagulants is permitted as long as
the INR or aPTT is within therapeutic limits (according to institution medical
standard) and the patient has been on a stable dose of anticoagulants for at
least two weeks at the time of randomization.

- Adequate liver function (within 14 days prior to randomization)

- Serum bilirubin ≤ 1.5 x ULN

- Serum transaminases ≤ 2.5 x ULN

- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must
demonstrate ≤ 1 g of protein in 24 hours

- Adequate postoperative GFR > 40 ml/min (estimates based on the Cockroft-Gault or
Jelliffe formula are sufficient)

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Exclusion Criteria

- Non-epithelial origin of the ovary, the fallopian tube or the peritoneum

- Borderline tumours (tumours of low malignant potential) and FIGO stage Ia - IIa
tumours

- Planned intraperitoneal cytotoxic chemotherapy

- Prior systemic anti-cancer therapy for ovarian cancer (for example chemotherapy,
monoclonal antibody therapy, tyrosine kinase inhibitor therapy or hormonal therapy)

- Surgery (including open biopsy) within 4 weeks prior to anticipated first dose of
bevacizumab (allowing for the fact that bevacizumab can be omitted from the first
cycle of chemotherapy). It is strongly recommended that an interval of 7 days is left
between the insertion of any central venous access devices (CVADs) and the onset of
bevacizumab treatment.

- Any planned surgery during the study treatment period plus 4 additional weeks to
allow for bevacizumab clearance

- Uncontrolled hypertension (sustained elevation of BP systolic > 150mmHg and/or
diastolic > 100mmHg despite antihypertensive therapy)

- Any previous radiotherapy to the abdomen or pelvis

- Significant traumatic injury during 4 weeks preceding the potential first dose of
bevacizumab

- History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI
of the brain is mandatory (within 4 weeks prior to randomization) in case of
suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to
randomization) in case of suspected spinal cord compression.

- History or evidence upon neurological examination of central nervous system (CNS)
disease, unless adequately treated with standard medical therapy e.g. uncontrolled
seizures

- Previous Cerebro-Vascular Accident (CVA), Transient Ischaemic Attack (TIA) or
Sub-Arachnoid Haemorrhage (SAH) within 6 months prior to randomization

- Fertile woman of childbearing potential not willing to use adequate contraception
(oral contraceptives, intrauterine device or barrier method of contraception in
conjunction with spermicidal jelly or surgically sterile) for the study duration and
at least 6 months afterwards

- Pregnant or lactating women

- Treatment with other investigational agents, or participation in another clinical
trial testing a drug within the past 4 weeks before start of therapy concomitantly
with this trial

- Malignancies other than ovarian cancer within 5 years prior to randomization, except
for adequately treated

- carcinoma in situ of the cervix

- and/or basal cell skin cancer

- and/or non-melanomatous skin cancer

- carcinoma in situ of the breast

- and/or early endometrial carcinoma as specified below. Patients may have
received previous adjuvant chemotherapy for other malignancies e.g. breast or
colorectal carcinoma if diagnosed over 5 years ago with no evidence of
subsequent recurrence.

- Patients with synchronous primary endometrial carcinoma, or a past history of primary
endometrial carcinoma, are excluded unless ALL of the following criteria for
describing the endometrial carcinoma are met

- Disease stage FIGO stage ≤ IA (tumour invades less than one half of the
myometrium)

- Known hypersensitivity to bevacizumab and its excipients, Chinese hamster ovary cell
products or other recombinant human or humanised antibodies

- Non healing wound, active ulcer or bone fracture. Patients with granulating incisions
healing by secondary intention with no evidence of facial dehiscence or infection are
eligible but require 3 weekly wound examinations

- History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to
randomization

- Clinically significant cardiovascular disease, including

- Myocardial infarction or unstable angina within 6 months of randomization

- NYHA ≥ Grade 2 Congestive Heart Failure (CHF)

- Poorly controlled cardiac arrhythmia despite medication (patients with
rate-controlled atrial fibrillation are eligible)

- Grade ≥ 3 peripheral vascular disease (i.e. symptomatic and interfering with
activities of daily living requiring repair or revision)

- Current or recent (within 10 days prior to randomization) chronic use of aspirin >
325 mg/day

- Pre-existing sensory or motor neuropathy ≥ Grade 2

- Evidence of any other disease, metabolic dysfunction, physical examination finding or
laboratory finding giving reasonable suspicion of a disease or condition that
contra-indicates the use of an investigational drug or puts the patient at high risk
for treatment-related complications

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Addresses

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    • AGO Study Group
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    • AGO Study Group
    • Jacobus Pfisterer, MD PhD 
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    • Anja Krüger 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.