A Phase III Randomized Study of Pegylated Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian or Peritoneal Carcinoma after Failure of Initial Platinum-Based Chemotherapy

Closed

Phase

Accrual

Published

Abbreviated Title

OVARIAN

Activated

08/15/2002

Closed

12/15/2004

Participants

NCORP, Members, Medical Oncologists, CTSU Institutions in the United States

Research committees

Gynecologic Cancer

Treatment

Carboplatin Pegylated Liposomal Doxorubicin

Eligibility Criteria Expand/Collapse

Histologically diagnosed epithelial ovarian carcinoma. Primary peritoneal and mixed mullerian tumors allowed. Borderline ovarian tumors not allowed. At time of initial staging laparotomy, surgically staged as FIGO Stage III or IV. Recurrence or disease progression with a progression-free and platinum-free interval of 6-24 months after first-line platinum-based chemotherapy. Consolidation therapy allowed during this interval provided it is completed at least 28 days prior to registration. Surgical debulking allowed provided at least 28 days before registration and recovered from all effects. No prior cumulative anthracycline in excess of 240 mg/m2. No prior pegylated liposomal doxorubicin. No prior abdominopelvic irradiation. Measurable or non-measurable disease. ANC >= 1,500, platelets >= 100,000, hemoglobin >= 10, creatinine <= 1.9, SGOT/SGPT <= 2 x IULN, alkaline phosphatase <= 2 x IULN, bilirubin <= IULN. Zubrod 0-1. No other therapy planned. No active or uncontrolled infection, brain metastases, severe gastrointestinal symptoms, Grade 2 or greater sensory neuropathy, or history of cardiac disease. Pregnant women not eligible. Some prior malignancies allowed (e.g. basal cell, squamous cell, in situ cervical).

Publication Information Expand/Collapse

2020

Association of Patient Demographic Characteristics and Insurance Status with Survival in Cancer Randomized Clinical Trials with Positive Findings

JM Unger;CD Blanke;M Leblanc;W Barlow;R Vaidya;M Fleury;SD Ramsey;DL Hershman JAMA Network Open Apr 1;3(4):e203842

PMid: PMID32352530 | PMC number: PMC7193331

2018

Value of Anti-Cancer Drugs in SWOG Phase III Clinical Trials: Evidence from Multiple Evaluation Mechanisms

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster #B-335

2010

Single agent carboplatin versus carboplatin plus pegylated liposomal doxorubicin in recurrentl ovarian cancer: final survival results of a SWOG (S0200) phase 3 randomized trial [PMC2836168; PMID20044128]

Maurie Markman;James Moon;S Wilczynski;AM Lopez;KM Rowland;DP Michelin;V Lanzotti;G Anderson;D Alberts Gynecologic Oncology 116(3):323-325

2008

Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of ititial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200) [PMC2276605; PMID17949799]

DS Alberts;PY Liu;SP Wilczynski;MC Clouse;AM Lopez;DP Michelin;VJ Lanzotti;M Markman Gynecologic Oncology 108:90-94

2007

Phase III randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy: Southwest Oncology Group Protocol S0200

DS Alberts;PY Liu;S Wilczynski;M Clouser;A Lopez;M Lange;V Lanzotti;M Markman Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#5551