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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
carboplatin
paclitaxel
debulking surgery
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    chemo/debulking surgery/IP chemo

    Arm Description

    neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)

    Outcomes

    Primary Outcome Measures

    Overall Survival
    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.
    Progression-Free Survival
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2001
    Last Updated
    December 8, 2015
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00008138
    Brief Title
    S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer
    Acronym
    S0009
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
    Keywords
    stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer, peritoneal cavity cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    62 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    chemo/debulking surgery/IP chemo
    Arm Type
    Experimental
    Arm Description
    neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
    Intervention Type
    Drug
    Intervention Name(s)
    carboplatin
    Other Intervention Name(s)
    carbo
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    paclitaxel
    Other Intervention Name(s)
    Taxol
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    debulking surgery
    Other Intervention Name(s)
    surgery, debulking, cytoreduction, laparotomy
    Intervention Description
    exploratory laparotomy, interval cytoreduction (to < 1 cm residual)
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Description
    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.
    Time Frame
    assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
    Title
    Progression-Free Survival
    Description
    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.
    Time Frame
    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.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amy D. Tiersten, MD
    Organizational Affiliation
    NYU Langone Health
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19138791
    Citation
    Tiersten AD, Liu PY, Smith HO, Wilczynski SP, Robinson WR 3rd, Markman M, Alberts DS. Phase II evaluation of neoadjuvant chemotherapy and debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube or primary peritoneal cancer: Southwest Oncology Group Study S0009. Gynecol Oncol. 2009 Mar;112(3):444-9. doi: 10.1016/j.ygyno.2008.10.028. Epub 2009 Jan 12.
    Results Reference
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    S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer

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