paywalled - Gynecologic Oncology - A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: GOG

ScienceDirect.com - Gynecologic Oncology - A phase II study of a urokinase-derived peptide (A6) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: A Gynecologic Oncology Group study

Conclusion

A6 was well tolerated but had minimal activity in patients with persistent or recurrent EOC/FTC/PPC.

Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavi - GOGty Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy - Full Text View - ClinicalTrials.gov

 WebMd:  ACETYL - L - CARNITINE (including other names)

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This study is not yet open for participant recruitment.

Verified April 2012 by National Cancer Institute (NCI)

First Received on December 14, 2011.   Last Updated on April 17, 2012   History of Changes

Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy - Full Text View - ClinicalTrials.gov

Purpose

RATIONALE: Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing chemotherapy.

U.S. - Planned Cooperative Group Merger Is Generating Concern - NCI clinical trials - gynecologic oncologists, funding, more common cancers, GOG....

A proposed overhaul of the National Cancer Institute’s clinical trials system has created anxiety among gynecologic researchers who fear projects in women’s cancer will be diminished in a scramble for funding with more common malignancies.......

Should stage IIIC ovarian cancer be further stratified by intraperitoneal vs. retroperitoneal only disease?: A GOG study

abstract: A randomized phase III trial of IV carboplatin and paclitaxel × 3 courses followed by observation versus weekly maintenance low-dose paclitaxel in patients with early-stage ovarian - GOG

Note: although a 3% difference of estimated recurrence rates (542 patients @ 3% = 16.26 patients/lives), the abstract does not allow for a description of the patient demographics eg. cell type, stage..., note also that as in past blogs the GOG studies include stage 1 and stage 11

OBJECTIVE:

To compare the recurrence-free interval (RFI) and safety profile in patients with completely resected high-risk early-stage ovarian cancer treated with intravenous (IV) carboplatin and paclitaxel with or without maintenance low-dose paclitaxel for 24weeks.

METHODS:

Eligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II epithelial ovarian cancer. All patients were to receive carboplatin AUC 6 and paclitaxel 175mg/m(2) q3 weeks×3 courses with random assignment to either observation or maintenance paclitaxel 40mg/m(2)/week×24weeks. Recurrence required clinical or radiological evidence of new tumor.

RESULTS:

There were 571 patients enrolled onto this study, of whom 29 were deemed ineligible due to inappropriate stage or pathology, leaving 542 patients. At least 3 cycles of treatment were administered to 524/542 (97%) of patients, and among those assigned to maintenance paclitaxel, 80% completed the regimen. The incidence of grade 2 or worse peripheral neuropathy (15.5% vs. 6%), infection/fever (19.9% vs. 8.7%), and dermatologic events (70.8% vs. 52.1%) was higher on the maintenance regimen (p<0.001). The cumulative probability of recurring within 5years for the maintenance paclitaxel regimen is 20% vs. 23% for surveillance (hazard ratio 0.807; 95% CI: 0.565-1.15). The probability of surviving 5years was 85.4% and 86.2%, respectively.

CONCLUSION:

Maintenance paclitaxel at 40mg/m(2)/week×24weeks added to standard dose AUC6 and paclitaxel 175mg/m(2)×3 doses provides no significant increase in RFI.

OXiGENE, Inc. - OXiGENE Announces First Patient Enrolled in Phase 2 Study of ZYBRESTAT in Patients With Ovarian Cancer (comparing Avastin alone)

"SOUTH SAN FRANCISCO, Calif., April 11, 2011 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that clinical investigators have enrolled the first patient in a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer. The study, which is being conducted by investigators from the Gynecologic Oncology Group (GOG), is expected to enroll approximately 105 patients with a primary endpoint of progression-free survival. OXiGENE expects results of the study to become available in early 2013.

"We believe that the combination of an anti-angiogenic agent with a vascular disrupting agent in the treatment of ovarian cancer has the potential to represent an entirely new treatment paradigm for patients with relapsed disease," said Bradley Monk, M.D., FACS, Professor of Gynecologic Oncology at Creighton University Hospital and lead investigator of the study."Patients with recurrent ovarian cancer have few therapeutic options, and ZYBRESTAT could become a valuable addition to current treatment modalities."

The study is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for ZYBRESTAT and a CRADA with Genentech for the development of bevacizumab. The aim of the trial, sponsored by the NCI's Division of Cancer Treatment and Diagnosis, is to determine if the combination of ZYBRESTAT and bevacizumab will enhance anti-tumor effects and further delay tumor progression when compared to bevacizumab alone....."

abstract: A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer: (GOG 146Q)

Nuclear P27 (gene) expression in benign, borderline (LMP) and invasive tumors of the ovary and its association with prognosis: A GOG group study

Abstract

Objective

Nuclear p27 expression was examined in non-invasive and invasive ovarian tumors from a cross-sectional study, and clinical relevance of p27 was evaluated in the primary tumors from women participating in two randomized phase III treatment trials.

Methods

An immunohistochemistry assay was used to detect p27 in formalin-fixed paraffin-embedded ovarian tumors from 3 distinct sources.

Research Highlights

► Low p27 expression is associated with malignant transformation of the ovary.
► A cyclin E to p27 ratio > 1.0 may be associated with shorter survival.
► Study required confirming increased recurrences with low p27 in early stage patients.

January 5, 2011 Gynecologic Oncology Group Survival - White Paper

January 5, 2011 Gynecologic Oncology Group Survival In 2010


cancerletter.com/downloads/20110203/download

"In 2010, the Institute of Medicine (IOM) produced a report recommending wide-ranging changes in the Cooperative Group program and, in response the National Cancer Institute (NCI) has proposed a reorganization of the nation’s cancer Clinical Trials program that would significantly change the program’s current structure....."

Cantech Letter interviews Brad Thompson President and CEO of Oncolytics Biotech (Reolysin, GOG, clinical trials)

NCI Cancer Bulletin: (The GOG Rare Tumor Committee)

Comparing First-Line Therapies for Mucinous Ovarian or Fallopian Tube Cancer

Name of the Trial
Phase III Study of Carboplatin and Paclitaxel with Versus without Bevacizumab Compared to Oxaliplatin and Capecitabine with Versus without Bevacizumab as First-Line Therapy in Patients with Newly Diagnosed Stage II-IV or Recurrent Stage I Mucinous Epithelial Ovarian or Fallopian Tube Cancer (GOG-0241). See the protocol summary.

media: Novel Study Using Reoviruses Against Ovarian Cancer Pushes Forward

Calgary-based Oncolytics Biotech Inc. recently announced that the Gynecologic Oncology Group (GOG) intends to conduct a randomized Phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN® in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

Gynecologic Oncology Group quality assurance audits: analysis and initiatives for improvement — Clin Trials

A Comparison of Quality-of-Life Domains and Clinical Factors in Ovarian Cancer Patients: A Gynecologic Oncology Group Study

CONCLUSION:
Ovarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients' QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.

Thomas J. Herzog, MD, Columbia University College of Physicians and Surgeons talks about liposomal doxorubicin, bevacizumab, and temsirolimus in patients with advanced malignancy/GOG reference to trials

Note: This is a repost of the video. Dr Herzog speaks briefly about the direction of GOG trials including the numerous drug combinations and trying to assess the best approaches.

Translational research in the Gynecologic Oncology

Translational research in the Gynecologic Oncology Group: Evaluation of ovarian cancer markers, profiles, and novel therapies.

Gynecologic Oncology Group (GOG) Notifies CTI That Continuation of GOG-212 Pivotal Trial of OPAXIO Maintenance Therapy in Front Line Ovarian Cancer Remains High Priority - MarketWatch

press release

March 4, 2010, 1:30 a.m. EST
Gynecologic Oncology Group (GOG) Notifies CTI That Continuation of GOG-212 Pivotal Trial of OPAXIO Maintenance Therapy in Front Line Ovarian Cancer Remains High Priority
GOG-218 Bevacizumab Results Do Not Influence Importance of GOG-212

SEATTLE, March 4, 2010 /PRNewswire via COMTEX/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that CTI received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership that the phase III GOG-212 clinical trial of CTI's OPAXIO(TM) used as maintenance therapy for ovarian cancer remains a high priority and enrollment will continue. The GOG made the statement to clarify that the recent results of the GOG-218 clinical trial bevacizumab in maintenance therapy for ovarian cancer has not influenced the importance of completing the GOG-212 clinical trial.