SWOG clinical trial number
S0009

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

Closed
Phase
Accrual
100%
Published
Abbreviated Title
OVARIAN
Activated
03/15/2001
Closed
02/01/2006
Participants
NCORP, Members, Surgeons

Research committees

Gynecologic Cancer

Treatment

Paclitaxel Carboplatin Surgery

Eligibility Criteria Expand/Collapse

Stage III epithelial ovarian cancer, primary peritoneal or fallopian tube cancer with a large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion. Stage IV with pleural effusion allowed; parenchymal liver, lung, or other distant metastases not allowed. Patient must be clinically deemed unlikely to be able to be optimally cytoreduced by evaluating surgeon. Patient must have adenocarcinoma by biopsy or cytology (non-mucinous histology) compatible with an epithelial ovarian, fallopian tube or peritoneal primary. Patients with tumors histologically classified as of borderline or low malignant potential not eligible. Patients with pleural effusions must have cytologic confirmation of adenocarcinoma. No prior chemotherapy, immunotherapy, or pelvic radiation for this cancer. Exploratory laparotomy allowed only if an aggressive tumor debulking procedure was not performed (e.g., BSO/TAH with omentectomy). Only minimal tumor resection for the purposes of diagnosis and palliation allowed (e.g., salpingo oophorectomy and/or partial omentectomy). No evidence of active or uncontrolled infection, congestive heart failure or cardiac arrhythmia. No history of myocardial infarction or angina 6 months prior to registration. No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding at time of registration. No >= Grade 2 CTC "Neuropathy-sensory" at the time of registration. No plans for concurrent antitumor treatment. Non-pregnant, non-nursing.

Publication Information Expand/Collapse

2016

Comorbidities and Risk of Chemotherapy-Induced Peripheral Neuropathy Among Participants 65 Years or Older in Southwest Oncology Group Clinical Trials

D Hershman;C Till;J Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology Sep 1;34(25):3014-3022; 2016 Jun 20 [Epub ahead of print]

PMid: PMID27325863 | PMC number: PMC5012713

Comorbidities and risk of chemotherapy induced peripheral neuropathy among participants in SWOG clinical trials

DL Hershman;C Till;JD Wright;D Awad;S Ramsey;W Barlow;L Minasian;J Unger Journal of Clinical Oncology 34, 2016 (suppl; abstr 10001); American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), oral presentation

2009

Phase II evaluation of neoadjuvant chemotherapy and interval 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 [PMID19138791]

AD Tiersten;PY Liu;HO Smith;SP Wilczynski;WR Robinson;M Markman;DS Alberts Gynecologic Oncology 112(3):444-449

Chemotherapy resistance as a predictor of progression-free survival in ovarian cancer patients treated with neoadjuvant chemotherapy and surgical cytoreduction followed by intraperitoneal chemotherapy: a Southwest Oncology Group Study [PMC2837883;PMID20130422]

AD Tiersten;J Moon;HO Smith;SP Wilczynski;WR Robinson;M Markman;JP Fruehauf;DS Alberts Oncology 77(6):395-399

Chemotherapy resistance as a predictor of progression-free survival in ovarian cancer patients treated with enoadjuvant chemotherapy and surgical cytoreduction followed by intraperitoneal chemotherapy: a Southwest Oncology Group study

AD Tiersten;PY Liu;HO Smith;SP Wilczynski;WR Robinson;M Markman;JP Fruehauf;DS Alberts Western Association of Gynecologic Oncologists (WAGO) Annual Meeting, poster presentation

2008

Phase II evaluation of neoadjuvant chemotherapy and interval debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube, or primary peritoneal cancer: A Southwest Oncology Group study

A Tiersten;P Liu;H Smith;SP Wilczynski;WR Robinson;M Markman;DS Alberts Gynecologic Oncology 108(3) suppl. 1:S3