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S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer (S0009)

8 december 2015 bijgewerkt door: Southwest Oncology Group

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

OBJECTIVES:

  • Evaluate the overall survival and progression-free survival in patients with stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer treated with neoadjuvant paclitaxel and carboplatin followed by surgery and adjuvant paclitaxel and carboplatin.
  • Estimate the percentage of these patients whose disease is successfully cytoreduced to less than 1 cm in diameter following neoadjuvant chemotherapy.
  • Evaluate the toxicity of this regimen in these patients.
  • Explore the relationship between tumor p53 expression, proliferation rate as measured by proliferating cell nuclear antigen and apoptotic rate, and human tumor cloning assay results at time of debulking surgery with progression-free survival and overall survival in these patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 35 days of receiving the third course of chemotherapy, patients with at least a 50% reduction in CA 125 undergo debulking surgery. Within 35 days of undergoing surgery, patients with a tumor reduction to below 1 cm receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 5 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 3 years.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

62

Fase

  • Fase 2

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 120 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer

    • Adenocarcinoma
    • Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion
    • Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant metastases not allowed)
    • No borderline or low-malignant potential tumors
  • Optimal cytoreduction clinically deemed unlikely
  • CA 125 at least 70 units/mL

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT no greater than 2 times ULN

Renal:

  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No congestive heart failure or cardiac arrhythmia
  • No myocardial infarction or angina within past 6 months

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding
  • No grade 2 or greater sensory neuropathy
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
  • No active or uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for this cancer

Chemotherapy:

  • No prior chemotherapy for this cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior pelvic radiation for this cancer

Surgery:

  • See Disease Characteristics
  • Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy with omentectomy)
  • Prior salpingo-oophorectomy and/or partial omentectomy allowed

Other:

  • No other concurrent anti-cancer therapy

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: chemo/debulking surgery/IP chemo
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
Geneesmiddel: carboplatin
pre-surgery - target AUC=6, Day 1 IV, q 21 days X 3 cycles post-surgery - target AUC=5, Day 1 IP, q 28 days X 6 cycles
Andere namen:
  • carbo
Geneesmiddel: paclitaxel
pre-surgery - 175 mg/m2 IV Day 1, q 21 days X 3 cycles post-surgery - 175 mg/m2 IV Day 1, q 28 days X 6 cycles AND 60 mg/m2 IP Day 8, q 28 days X 6 cycles
Andere namen:
  • Taxol
Procedure: debulking surgery
exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
Andere namen:
  • chirurgie
  • laparotomie
  • debulking
  • cytoreductie

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival
Tijdsspanne: assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
Progression-Free Survival
Tijdsspanne: Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.
Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.
Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Southwest Oncology Group

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Amy D. Tiersten, MD, NYU Langone Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2001

Primaire voltooiing (Werkelijk)

1 september 2009

Studie voltooiing (Werkelijk)

1 november 2009

Studieregistratiedata

Eerst ingediend

6 januari 2001

Eerst ingediend dat voldeed aan de QC-criteria

26 januari 2003

Eerst geplaatst (Schatting)

27 januari 2003

Updates van studierecords

Laatste update geplaatst (Schatting)

8 januari 2016

Laatste update ingediend die voldeed aan QC-criteria

8 december 2015

Laatst geverifieerd

1 december 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000068380
  • U10CA032102 (Subsidie/contract van de Amerikaanse NIH)
  • S0009 (Andere identificatie: SWOG)

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