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UPDATE ON GCIG TRIALS FOR EPITHELIAL OVARIAN CANCER Christian Marth. Closed Trials. EORTC 55971. Upfront Surgery vs Neoadjuvant Chemotherapy Patients closed / 550 Leading EORTC Participating NCIC CTG Presentated at IGCS 2008. in press. Tarceva Trial EORTC 55041.

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slide3

EORTC 55971

Upfront Surgery vs Neoadjuvant Chemotherapy

Patients closed / 550

Leading EORTC

Participating NCIC CTG

Presentated at IGCS 2008

in press

slide4

Tarceva Trial EORTC 55041

Tarceva consolidation 2 years

Primary Chemotherapy

Control

Patients closed / 835

Leading EORTC

Participating AGO-AUSTRIA, ANZGOG, GINECO,

MRC/NCIC, MANGO

slide5

ICON-7

TC ± BEVACIZUMAB

Patients closed / 1520

Leading MRC/NCRI

Participating NCIC CTG, AGO OVAR, GINECO, GEICO

EORTC, ANZGOG, NSGO

slide6

GOG 218

CT vs CT + Bevacizumab Placebo vs

CT + Bevacizumab concurrent and extended

Patients closed / 1800

Leading GOG

Participating ECOG, NCCTG, NSABP, SWOG

slide7

Calypso

Published Ahead of Print on May 24, 2010

slide8

AGO-OVAR-9

Carbo Paclitaxel +/- Gemcitabine

Patients closed 1742

Leading AGO-OVAR

Participating GINECO, NSGO,

in press

slide9

SCOTROC 4

Carbo Flat Dosing vs Intrapatient Dose Escalation

Patients closed 932

Leading SGCTG

Participating ANZGOG

Manuscript in preparation

slide10

HECTOR

Carbo Topo vs Chemo (CT or CG) in recurrent

Platinum-sensitive ovarian cancer

Patients closed 550

Leading NOGGO/AGO-OVAR

Participating AGO-AUSTRIA, GEICO

slide11

AGO-OVAR-OP.2 DESKTOP II

Evaluation of predictive factors for complete resection in platinum-sensitive recurrent ovarian cancer

Patients closed/412

Leading AGO-OVAR

Participating AGO-AUSTRIA, MITO,

selected Canadian+Australian centers

Report IGCS 2008, in preparation

slide13

AGO-OVAR-12

Carbo Paclitaxel +/- BIBF 1120 (Vargatef)

Patients 146 / 1300 (2:1 random)

Leading AGO-OVAR

Participating AGO-Austria, BGOG, GINECO, MANGO, MITO, NSGO, US Oncology

slide14

AGO-OVAR 16

Pazopanib consolidation 1 yr

First Line Chemotherapy

Control

Patients 752 / 900

Leading AGO-OVAR

Participating

AGOAustria, ANZGOG, BGOG, GEICO, GINECO, ICORG, JGOG, KGOG, MANGO, MITO, NSGO, US-Sites: California Consortium, NY GOG, SWOG

slide15

AGO – OVAR OP.3 (LION)

Lymphadenectomy In Ovarian Neoplasms

epithelial invasive

ovarian cancer

FIGO IIB - IV

ECOG 0/1 and

no CI against LNE

no visible extra-

and intra-abdominal

tumor residuals

no bulky lymph nodes

System. Lymphadenectomy

  • pelvic
  • para-aortic

R

184/640

no Lymphadenectomy

Endpoints: OS, PFS, QoL Strata: centre, PS ,age

Supported by Deutsche Forschungsgemeinschaft

slide16

JGOG-3017 Clear Cell Carcinoma

CT vs CDDP + Irinotecan

Patients 541 / 600

Leading JGOG

Participating GINECO, GOG, KGOG, MITO, SGCTG

slide17

MITO-7

Weekly CT vs 3-weekly CT (QoL)

Patients 227 / 400

Leading MITO

Participating MaNGO

slide18

MITO-8

LipDox vs CT cross-over

in 6-12 m platinum-free interval

Patients 46 / 253

Leading MITO

Participating MaNGO, AGO-OVAR

slide19

Aurelia

Bevacizumab plus chemotherapy vs chemotherapy alone in patients with platinum-resistant EOC

Patients 110 / 332

Leading GINECO

Participating AGO-OVAR, GEICO, MITO, NSGO

slide20

AGO-OVAR-OP.4 DESKTOP III

Cytoreductive surgery vs NO surgery

in platinum-sensitive recurrent EOC

Patients 0 / 385 activated June 1

Leading AGO-OVAR

Participating ?

slide21

CHORUS

Upfront Surgery vs Neoadjuvant Chemotherapy

Patients 535 / 550

Leading MRC

Participating

slide22

ICON6A Randomised Trial of Concurrent Cediranib (with Platinum-based Chemotherapy) and Maintenance Cediranib in Women with Platinum-Sensitive Relapsed Ovarian Cancer

slide25
mEOC

A multicentre randomised factorial trial comparing oxaliplatin + capecitabine, bevacizumab and carboplatin + paclitaxel in patients with previously untreated mucinous Epithelial Ovarian Cancer (mEOC)

mEOC is an intergroup study with two identical protocols

from GOG and NCRI with a single analysis

Cancer Research UK & UCL Cancer Trials Centre

meoc gog 241 2x2 factorial trial design
mEOC/GOG#241 2x2 Factorial Trial Design

Mucinous ovarian cancer FIGO stages II–IV OR recurrent stage I; No previous chemotherapy; >18yrs; PS=0-2

Randomise

(332 patients – 83 patients in each arm)

Oxaliplatin & Capecitabine

6 cycles q 21d

Bevacizumab 15mg/kg q3 w

5 or 6* cycles

Carboplatin & Paclitaxel

6 cycles q 21d

Oxaliplatin & Capecitabine

6 cycles q 21d

Oxaliplatin & Capecitabine

6 cycles q 21d

Bevacizumab 15mg/kg q3 w

5 or 6* cycles

Clinical assessment every 6 weeks for 36 weeks

Telephone call at week 3 between every 6-week visit

Bevacizumab 15mg/kg q3 weeks for 12 cycles

Clinical assessment every 6 weeks for 36 weeks

Response assessment:

CT scans are carried out post cycle 3 of chemo, 1 month after completion of cycle 6, then 3 monthly for Year 1

Follow up: 3 monthly years 1-2, 6 monthly years 3-5

*Bevacizumab can be omitted from the first cycle of if chemotherapy must be started within 4 weeks of surgery.

slide27

An international three-stage randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian cancer.

slide28

ARM1: C q 3/52

P q 3/52

(current std)

Surgery (IPS)

Chemotherapy

6 cycles

ARM2: C q 3/52

P q 1/52

Randomisation

ARM3: C q 1/52

P q 1/52

Chemotherapy

(x 3)

Surgery (DPS)

Chemotherapy

( x 3)

(A) Immediate Primary Surgery (IPS)

One trial with pre-specified stratification for IPD v DPS

(B) Delayed Primary Surgery (DPS)

  • Cycle 3 administered as standard 3-weekly cycle in all patients for DPS
treatment regimens
Arm 1- Carboplatin AUC5 q3w

Paclitaxel 175mg/m2 q3w

(standard of care)

Arm 2- Carboplatin AUC5 q3w

Paclitaxel 80mg/m2 q1w

(JGOG 3016 regimen)

Arm 3- Carboplatin AUC2 q1w

Paclitaxel 80mg/m2 q1w

1485 women recruited over 3 years

Treatment Regimens
slide30

International randomised phase III study of a PARP inhibitor versus liposomal doxorubicin or topotecan for ovarian cancer patients relapsing following previous platinum therapy and carrying a deleterious germline BRCA1 or BRCA2 mutation

540 patients over 4.5 years with 1 yr FU

  • Primary variable:
    • PFS
  • Secondary variables:
    • ORR by RECIST
    • Ca125 response (GCIG)
    • OS
slide31

iPocc Trial

IntraPeritoneal therapy for Ovarian Cancer with Carboplatin

(GOTIC-001 / JGOG3019)

A Randomized Phase II/III Trial of 3 Weekly Intraperitoneal versus Intravenous Carboplatin in Combination with Intravenous Weekly Dose-Dense Paclitaxel for Newly Diagnosed Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Study Chair

Keiichi Fujiwara

Saitama Medical University International Medical Center

slide32

Schema

Epithelial Ovarian Cancer

Stages II-IV

Including Bulky Tumor

RANDOMIZATION

Paclitaxel 80 mg/m2 IV Day1,8,15

Carboplatin AUC 6 IP

Q21, 6-8 Cycles

Paclitaxel 80 mg/m2 IV Day1,8,15

Carboplatin AUC 6 IV

Q21, 6-8 Cycles

Dose dense−TCiv

Dose dense−TCip

Primary Endpoint: PFS Secondary Endpoint: OS, Toxicity, QOL

Accrual Goal: 746 pts / 511 events

slide33

NCIG CTG OV21

Patients with EOC

3-4 cycles neoadjuvant chemo

Initial surgery: < 1 cm residual

3 cycles

d1 IV Carbo/Taxol

3 cycles IP/IV

d1 CDDP/Carbo IP and Taxol IV

d8 IP Taxol 60mg/m2

d8 IV Taxol 60mg/m2

Endpoints: PFS and OS

slide34

Diagnostic biomarkers

Patients diagnosed with EOC

3-4 cycles neoadjuvant chemo

Markers of primary chemoresistance

Primary surgery:> 1 cm residual

Or patient not entered in OV21

Primary surgery:

< 1 cm residual

OV21 patient

No surgery

+/_ progressive disease

Specific markers for IP vs. IV

Disease progression

Markers for acquired chemoresistance

ovatyon
OVATYON

Relapsed ovarian cancer (n=588)

with platinum-free interval (PFI) of 6-12 months

Randomization

(strata: ECOG, Measurable disease, PFI)

PLD 30 mg/m2 1 hour i.v. + Carboplatin AUC 5 30-60 min i.v. on day 1 q4weeks

Up to 6 cycles or progression

PLD 30 mg/m2 1 hour i.v. + Trabectedin 1.1 mg/m2 3 hoour i.v. on day 1 q3weeks

Up to 6 cycles or progression

3rd line chemotherapy: at investigator discretion

3rd line chemotherapy: platinum rechallenge

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