Gynecologic Oncology Group Uterine Corpus Trials: GCIG

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Gynecologic Oncology GroupUterine Corpus Trials
GCIG

• David Scott Miller, M.D., F.A.C.O.G., F.A.C.S.
• Director and Dallas Foundation Chair in
  Gynecologic Oncology
• Professor of Obstetrics Gynecology
• University of Texas Southwestern Medical Center
• Dallas, Texas, U.S.A.

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GOG0249

• Eligible Stage I-IIA endometrial carcinoma, with
  high-intermediate risk factors, Stage IIB
  (occult) endometrial carcinoma (any histology),
  with or without risk factors, and Stage I-IIB
  (occult) serous or clear cell endometrial
  carcinoma, with or without other risk features
• TREATMENT RANDOMIZATION
• Regimen I Pelvic Radiation Therapy (4500/25
  fractions-5040 cGy/28 fractions) over 5-6 weeks
  Optional Vaginal Cuff Boost ONLY for Stage II
  patients and Stage I patients with papillary
  serous and clear cell carcinomas
• OR
• Regimen II Vaginal Cuff Brachytherapy 3
  cycles of chemotherapy consisting of Paclitaxel
  175 mg/m2 (3hr) Carboplatin AUC 6 q 21 days
  chemotherapy to start within 3 weeks of
  initiating brachytherapy

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PHASE III TRIAL OF PELVIC RADIATION THERAPY
VERSUS VAGINAL CUFF BRACHYTHERAPY FOLLOWED BY
PACLITAXEL/CARBOPLATIN CHEMOTHERAPY IN PATIENTS
WITH HIGH RISK, EARLY STAGE ENDOMETRIAL CANCER
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GOG0249

• Objectives
• Recurrence free survival
• Survival
• Patterns of failure
• QOL
• Stats
• 49 decrease in recurrence/death
• 85 gt 92 3 yr RFS
• N 562
• Activated 23 Mar 2009

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Uterine Corpus Committee GOG0249 BIQSFP

• UC, QOL CEM collaboration

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Uterine Corpus Committee0184R

• GOG0258 (UC0704) A Randomized Phase III Trial
  of Cisplatin and Tumor Volume Directed
  Irradiation Followed by Carboplatin and
  Paclitaxel vs. Carboplatin and Paclitaxel for
  Optimally Debulked, Advanced Endometrial
  Carcinoma

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GOG258
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GOG0258

• Enroll patients with either surgical stage III or
  IVA endometrial carcinoma
• TREATMENT RANDOMIZATION
• REGIMEN I Cisplatin 50 mg/m2 IV Days 1 and
  28plus Volume-directed radiation therapy
  forfollowed by Carboplatin AUC 6 plus Paclitaxel
  175 mg/m2 q 21 days for 4 cycles
• Or
• REGIMEN II Carboplatin AUC 6 plus Paclitaxel 175
  mg/m2 q 21 days for 6 cycles

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GOG0258

• Objectives
• Recurrence free survival
• Survival
• Adverse effects
• Stats
• 28 decrease recurrence/death
• 61 gt 70 3 yr RFS
• N 804

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Uterine Corpus Committee Pelvic Recurrence

• 33 99 has resulted in
• TAH-BSO lymphadenectomy alone
• fewer using adjuvant WPRT
• GOG0238 A Randomized Trial of Pelvic
  Irradiation With or Without Concurrent Weekly
  Cisplatin in Patients With Pelvic-Only Recurrence
  of Carcinoma of the Uterine Corpus

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GOG0238
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GOG0238

• Objectives
• PFS
• Sites of recurrence
• OS
• Stats
• Phase II-III
• Interim analysis gt 60 failures
• Opened Feb 08
• N 164

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209R

• DTM0834 A three arm randomized phase II study
  of paclitaxel/carboplatin/bevacizumab,
  paclitaxel/carboplatin/everolimus and
  ixabepilone/carboplatin as initial therapy for
  measurable stage III or IVA, stage IVB, or
  recurrent endometrial cancer

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Uterine Corpus Committee188R

• GOG0250 Randomized Phase II Trial of
  Temsirolimus or the Combination of Hormonal
  Therapy Temsirolimus in Women With Advanced or
  Recurrent Endometrial Cancer

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Uterine Corpus Committee150R 161R

• GOG0261 (UC0701) Randomized Phase III Trial of
  Carboplatin plus Paclitaxel versus Ifosfamide
  plus Taxol in Patients with Advanced, Persistent
  or Recurrent Carcinosarcoma

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GOG0261
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GOG261

• Objectives
• OS
• PFS
• Toxicity
• QOL

• Stats
• Noninferiority
• Death rate lt 11
• N 415, (264 deaths)

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Uterine Corpus CommitteeFuture plans
Leiomyosarcoma

• GOG0250 Randomized Phase III Evaluation of
  Docetaxel, Gemcitabine, G-CSF /- Bevacizumab
  in the Treatment of Recurrent or Advanced
  Leiomyosarcoma

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Uterine Corpus Committee Future plans
Leiomyosarcoma
GOG0250

• SCHEMA
• Enroll patients with uterine LMS, measurable
  disease, no prior cytotoxic therapy
• STRATIFY for prior whole pelvic radiation
• Then RANDOMIZE to
• REGIMEN I Gemcitabine 900 mg/m2 IV over 90
  minutes days 1 and 8
• plus Docetaxel 75 mg/ m2 IV over 60 minutes day
  8
• every 3 weeks (one cycle) until disease
  progression or adverse effects prohibit further
  therapy
• or
• REGIMEN II Gemcitabine 900 mg/m2 IV over 90
  minutes days 1 and 8
• plus Docetaxel 75 mg/ m2 IV over 60 minutes day
  8
• plus Bevacizumab 15 mg/kg IV over 90 minutes day
  1
• every 3 weeks (one cycle) until disease
  progression or adverse effects prohibit further
  therapy

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GOG0250

• Objectives
• PFS
• RR
• OS
• Toxicity

• Stats
• 40 increase PFS
• 4 gt 6.7 mos
• N 130

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A Phase II Study to Determine the Response to
Second Curettage as Initial Management for
PersistentLow Risk, Non-Metastatic Gestational
Trophoblastic Neoplasia
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Concept

• Biweekly dactinomycin now needs to be tested
  against 8-day MTX/FAR, arguably the most commonly
  used regimen worldwide. The 8-day regimen has a
  similar primary response but a vastly different
  cost, resource and utility profile, and it has
  never been subjected to the scrutiny of a
  multi-centred RCT.