OVARIAN CANCER and US: clincial trials

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Showing posts with label clincial trials. Show all posts
Showing posts with label clincial trials. Show all posts

Wednesday, February 29, 2012

( Italy) Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence - Full Text View - ClinicalTrials.gov



Official Title:
Surgery Plus Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) Versus Surgery Alone in Patients With Platinum-sensitive First
Recurrence of Ovarian Cancer: a Prospective Randomized Multicenter Trial

Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) in Ovarian Cancer Recurrence (HORSE)

Purpose
The purpose of this study is to determine the role of surgery followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) versus surgery
alone in patients with platinum-sensitive first recurrence of ovarian cancer. Moreover it is a prospective randomized multicenter trial, aimed
to investigate the prognostic role of surgery plus HIPEC versus surgery alone in terms of progression free interval, overall survival, morbidity
and mortality, second recurrence pattern, quality of life with EORTC QLQ-C30 and QLQ OV28 questionnaires.

This study is currently recruiting participants.
Verified February 2012 by Catholic University of the Sacred Heart

First Received on February 20, 2012. Last Updated on February 28, 2012 History of Changes
Sponsor: Catholic University of the Sacred Heart
Information provided by (Responsible Party): Prof. Giovanni Scambia, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01539785

Friday, August 13, 2010

Future Medicine - Full Text Cancer pharmacogenomics: do cancer cell lines have the right stuff?



Note: cell 'lines' (test tube) vs  patient tumors

"....But with all the effort and money being put into pharmacogenomics research using cancer cell lines, it is appropriate to ask: how faithfully do cancer cell lines represent the tumors that they are being used to model?"

"Next, do cancer cell lines behave similarly to the tumors they are intended to model to be useful for pharmacogenomics research? First, cancer cell lines are more appropriate for assessing the response to cytotoxic anticancer drugs, rather than the response to newer biologic agents which exert their anti-tumor effects via mechanisms other than eliciting cell death. Second, an important consideration to keep in mind when using cancer cell lines for pharmacogenomics research is that cell lines are generally more sensitive to cytotoxic agents than solid tumors.

"Another important question is: how well does testing in cancer cell lines predict responses in clinical trials with real world patients? When assessing whether there is a correlation between drug activity in Phase II clinical trials and preclinical activity in cancer cell line models, one study found that preclinical activity did not correlate with Phase II response, with the exception of non-small-cell lung cancer [5].

However, ..........It is becoming more and more apparent that the process of culturing cells in vitro alters the genetic make-up of the cancer cell lines."

Sunday, August 08, 2010

abstract: How to follow-up patients with epithelial ovarian cancer : Current Opinion in Oncology



How to follow-up patients with epithelial ovarian cancer
Miller, Rowan E; Rustin, Gordon JS

Abstract

Purpose of review:
Despite optimal primary treatment most patients with advanced epithelial ovarian cancer will relapse. This review discusses the controversy regarding surveillance and the timing of treatment for recurrent disease.

Recent findings
: Routine physical examination has a limited role in the detection of recurrent ovarian cancer. PET/computed tomography (CT) has been shown to be useful in detecting small volume disease not apparent on traditional imaging in patients with suspected recurrence based on symptoms and/or rising CA125. The results of PET/CT can alter treatment plans and have particular use in guiding site-directed therapy. The benefits of early detection and systemic treatment of recurrence are now in doubt following the presentation of the MRC/EORTC CA125 surveillance trial. The impact on survival of secondary cytoreductive surgery requires more investigation.

Summary:
Uncertainties remain in the surveillance and timing of treatment for relapsed disease. Patients should be informed of these uncertainties and become involved in decisions regarding their follow-up.

Wednesday, July 14, 2010

JAMA -- Letter: bias and trials stoped for early benefit (5)



Letters
Bias and Trials Stopped Early for Benefit
Scott M. Berry; Bradley P. Carlin; Jason Connor
JAMA 2010; 304: 156. [Extract] [Full text] [PDF]


Letters
Bias and Trials Stopped Early for Benefit
Edward L. Korn; Boris Freidlin; Margaret Mooney
JAMA 2010; 304: 157-a-158-a. [Extract] [Full text] [PDF]


Letters
Bias and Trials Stopped Early for Benefit
Steven Goodman; Donald Berry; Janet Wittes
JAMA 2010; 304: 157. [Extract] [Full text] [PDF]


Letters
Bias and Trials Stopped Early for Benefit—Reply
Gordon H. Guyatt; Dirk Bassler; Victor M. Montori
JAMA 2010; 304: 158-a-159-a. [Extract] [Full text] [PDF]


Letters
Bias and Trials Stopped Early for Benefit
Susan S. Ellenberg; David L. DeMets; Thomas R. Fleming
JAMA 2010; 304: 158. [Extract] [Full text] [PDF]

Monday, June 28, 2010

Reply to M. Markman -- Ferrandina 28 (19): e321 -- Journal of Clinical Oncology



Markman:  Serious Ethical Dilemma of Single-Agent Pegylated Liposomal Doxorubicin Employed As a Control Arm in Ovarian Cancer Chemotherapy Trials -- Markman JCO commentary

  Ferrandina Response to Markman:

http://jco.ascopubs.org/cgi/content/full/28/19/e321?cmpid=jco_etoc_1July2010
"...Overall, I think that there will be no need for institutional review boards of community-based centers or universities to take up a formal position in this context. Indeed, I think that the more and more diffuse use in the clinical practice of PLD 40 mg/m2 will be, in and by itself, stronger than any regulatory rules, and that the lower and safer PLD dose level will tacitly replace the US Food and Drug Administration–approved dosage in clinical trials.

Time has already come for this change: looking through the randomized clinical trials utilizing PLD as a control arm, we found that four (NCT00976911 [ClinicalTrials.gov] , NCT00913835 [ClinicalTrials.gov] , NCT00635193 [ClinicalTrials.gov] , NCT00657878 [ClinicalTrials.gov] ) of seven of the ongoing studies are already employing the PLD dosage of 40 mg/m2 instead of 50 mg/m2 (www.clinicaltrials.gov."

Serious Ethical Dilemma of Single-Agent Pegylated Liposomal Doxorubicin Employed As a Control Arm in Ovarian Cancer Chemotherapy Trials -- Markman JCO commentary



"...It is essential that those reading this letter do not misinterpret its meaning. There is absolutely no intent in this discussion to vilify any individual, organization, or company involved in the oncology drug development paradigm. It is unquestionably the case that all working in this arena have as their major goal the advancement of antineoplastic strategies that are effective, relatively safe, and that improve the survival and quality of life of patients with cancer.

Tuesday, May 18, 2010

NCI: Talking About Trials: Overcoming Bottlenecks in Clinical Communication (enrolment)



".......“Patient refusal rates may be less of a problem than low rates of trial offers,” wrote the authors."

NCI Cancer Bulletin Insurance Coverage Expanding for Cancer Clinical Trials/costs




NCI Cancer Bulletin for May 18, 2010 - SPECIAL ISSUE



Additional Clinical Trials Resources

Cancer Clinical Trials at NIH

NCI supports cancer clinical trials across the country (U.S) through its extramural research program. Meanwhile, on NIH’s main campus, the Institute’s intramural researchers in the Center for Cancer Research (CCR) conduct hundreds of trials each year at the NIH Clinical Center in Bethesda, MD, and these trials often differ from those available elsewhere.
While some cancer centers also offer early-stage clinical trials, the difference is that CCR focuses almost exclusively on early-stage trials, said Dr. Bill Dahut, CCR’s clinical director.

NCI’s intramural program is able to pay the transportation costs for patients who are enrolled in Clinical Center trials. This allows CCR to see many more patients with rare cancers, or rare subtypes of common cancers, than other research sites because CCR can fly in patients from around the country to be treated in investigational studies.

One commonly cited barrier to entering clinical trials is the worry among both patients and their physicians of losing control. “An important point about treatment at NCI is that everything we do here for patients is done in close collaboration with their local physicians back home,” Dr. Dahut explained. “Our physicians provide expert clinical care to patients while they are being treated on protocol at NCI, but our physicians can see patients only while they are at the Clinical Center. Thus, continued care by local physicians is incredibly important to allow patients to access standard treatments or other trials not available here. Local physicians must remain closely involved with patients on NCI studies because side effects, from the cancer or the therapy, may occur when the patient is home and far from Bethesda.”

Patients and physicians interested in exploring cancer clinical trials at NIH can visit CCR’s clinical trials Web site. The site includes detailed descriptions of clinical trials currently recruiting patients; information for the general public about clinical trials and participating in trials at NCI; and information for health professionals about referring patients, the Center’s clinical programs and investigators, and ways to keep up to date with CCR research and opportunities.

“We’d really like to encourage physicians to join our mailing list,” said Susan McMullen, patient outreach and recruitment coordinator for CCR’s Office of the Clinical Director.  “One of the barriers to recruiting patients at NIH is that our doctors don’t have a patient base outside of clinical trials to draw from, so we rely on community doctors to refer patients to us.”

Family Cancer Registries

For some families, the tragedy and sorrow of losing a relative to cancer is repeated as family member after family member is diagnosed with the same disease.
To determine what genetic factors may be at work and how environmental influences alter those genetic risks, researchers rely on those affected by familial cancer to participate in family cancer registries.

“Our major goal in studying these families is to identify what are called high-risk susceptibility genes,” explained Dr. Peggy Tucker, director of the Human Genetics Program and chief of the Genetic Epidemiology Branch in NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “We then try to understand the function of those genes, how they confer risk, and what other factors within the family modify risk.

“Ultimately, we want to be able to alter the risk of cancer in these families either by identifying susceptibility factors we can modify—for example, avoiding sun exposure in melanoma families—or designing interventions that can affect risk—such as prophylactic oophorectomy for women in families with high risk of both breast and ovarian cancer,” she said.

Family cancer registry studies can also help inform researchers about cancer susceptibility risks in the general population. For example, researchers identified dysplastic nevi as a major risk factor for melanoma by studying families at high risk of melanoma.

Researchers at NCI first began conducting family registry studies in the mid-1960s. These long-term studies follow families through successive generations, and allow researchers to examine the role of inherited high-susceptibility genes and cancer. Today, DCEG researchers are studying families with a number of inherited cancers or cancer-susceptibility syndromes, and researchers in NCI’s Division of Cancer Control and Population Sciences (DCCPS) sponsor the Breast and Colon Cancer Family Registries.

Whereas DCEG’s family registries are conducted at the NIH Clinical Center, the family registries based in DCCPS are found throughout the United States, Australia, and Canada. “Currently, we have about 78,000 men and women from nearly 26,000 families participating in these registries,” said Dr. Sheri Schully, program officer for the DCCPS family registries program. “The main objective of these registries is to identify and characterize cancer susceptibility genes, but the investigators also look at gene–gene and gene–environment interactions as well.”

Although family registry studies do not provide treatment to participating families, investigators often provide test results that can help family members learn which of them may be at higher risk because of certain susceptibility genes, such as mutations in the BRCA1 and BRCA2 genes or those associated with Lynch syndrome, said Dr. Schully.
Additionally, the studies are an opportunity for people who are often desperate for answers to ask questions.

“We like to think it’s a positive experience for them because they have a whole day at NIH to meet with physicians and nurses who know a lot about the disease,” Dr. Tucker explained. “We try to keep them updated with new findings about the diagnosis and management of the cancer that affects their family, and they know they can always come to us for referrals for care of the disorders that we’re studying.”

Learn More About Clinical Trial Enrollment....

Sunday, May 16, 2010

2010 ASCO Annual Meeting | Meeting Program | What Is New This Year 2010 annual meeting - Trials in Progress Poster Session



Note: the program is now online for the annual meeting June 2010 (searchable) (http://www.asco.org)

What's New This Year

Trials in Progress Poster Session

The new Trials in Progress Poster Session will facilitate awareness of and dialogue about open, ongoing clinical trials. It differs from other Poster Sessions in that

* outcomes data or results are not included
* the goal is to promote discussion among trial investigators, to encourage recruitment of new investigators or sites, and to stimulate discussion of successor or confirmatory trials
* the focus is on the background of the science behind the trial, and preclinical or earlier-phase data (preferably with references) is encouraged

The Trials in Progress Poster Session will be held Monday, June 7 from 8:00 AM to 12:00 PM. All Meeting attendees are welcome to attend this new session.

Saturday, April 17, 2010

Journal of Oncology Practice - Home Page - Survey of Cooperative Groups regarding NCI trials



Note: as of the timing of this post, these articles are freely available

Early Release Articles *NEW*

1) Timing Is Everything Zon
2) Challenges to National Cancer Institute–Supported Cooperative Group Clinical Trial Participation: An ASCO Survey of Cooperative Group Sites Baer et al

Wednesday, April 14, 2010

media item: Magee-Womens Hospital - ovarian cancer recruitment - ABT-888/PARP



Drug Tested Against Women's Cancers
Pittsburgh Post-Gazette (PA) - Apr. 14, 2010

Apr. 14--Magee-Womens Hospital of UPMC is recruiting patients with recurrent ovarian, fallopian tube or peritoneal cancers who have already had chemotherapy for a national, Phase 2 clinical trial of the drug ABT-888.

ABT-888 works by targeting the PARP family of enzymes, which are responsible for a wide variety of cancer cell processes, principal investigator Kristin Zorn said. The PARP pathway is one of the mechanisms used by cancer cells to repair damage caused by chemotherapy....cont'd

Wednesday, February 03, 2010

Stanford's Canary Center strives to find cancer sooner than every before - 2/01/10 - San Francisco News



"Scientists at the Canary Center say their first blood test, developed for ovarian cancer, is about to begin phase one clinical trials at Stanford. The first patient group will be women at high risk for ovarian cancer."

Monday, January 25, 2010

Clinical Trials Matching Service - Ovarian Cancer National Alliance



"Women can explore clinical trials by visiting the Ovarian Cancer National Alliance Clinical Trials Matching Service online or by calling (800) 535-1682."