AzTrials
AzTrials

Fallopian Tube Clear Cell AdenocarcinomaPhase 2NCT00888615

Elesclomol Sodium and Paclitaxel in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 2 study testing Elesclomol Sodium and Paclitaxel in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by GOG Foundation at 163 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Elesclomol Sodium and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
163 sitesUnited States
Study dates
13 Dec 2010to 31 Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
  • Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
  • Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol for the same patient population
  • Patients must have a GOG performance status of 0, 1, or 2
Show all 29Show fewer
  • Patients must have baseline lactate dehydrogenase (LDH) levels =< 0.8 x upper limit of normal (ULN)
  • Recovery from effects of recent surgery, radiotherapy, or chemotherapy
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration
  • Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration
  • Prior therapy
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment
  • Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent or persistent disease, including retreatment with initial chemotherapy regimens; (Note: optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy; non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a phase II trial)
  • Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
  • Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) hormones, monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Patients must be considered platinum resistant or refractory according to standard GOG criteria, i.e., have had a treatment-free interval following platinum of less than 6 months, or have progressed during platinum-based therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN
  • Alkaline phosphatase less than or equal to 2.5 x ULN
  • Neurologic function: neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information
  • Patients must meet pre-entry requirements
  • Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
  • Cautions and prohibited medications/treatments
  • Since elesclomol is a substrate for cytochrome P450 family 2, subfamily C, polypeptide 9 (CYP2C9), cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6), cytochrome P450 family 2, subfamily C, polypeptide 19 (CYP2C19), and cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) and an inducer of CYP3A4, cytochrome P450 family 1, subfamily A, polypeptide 2 (CYP1A2), cytochrome P450 family 2, subfamily A, polypeptide 6 (CYP2A6), and cytochrome P450 family 2, subfamily E, polypeptide 1 (CY2E1), it is recommended that the following be used with caution: sensitive substrates of CYP3A4, CYP1A2, and CY2E1, and strong inhibitors and inducers of CYP2C9, CYP2D6, CYP2C19, and CYP3A4

Who cannot join

  • Patients who have had prior therapy with elesclomol or prior second-line cytotoxic chemotherapy
  • Patients who have received radiation to more than 25% of marrow-bearing areas
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
  • Patients who are pregnant or breastfeeding

Trial locations and contacts

163 sites in 1 country.

163 sites in 1 country

United States163 sites

  • Jefferson Abington Hospital

    Abington, Pennsylvania, 19001

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Delaware Radiation Oncology

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Christiana Care - Union Hospital

    Elkton, Maryland, 21921

  • University of Connecticut

    Farmington, Connecticut, 06030

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Hendersonville Hematology and Oncology at Pardee

    Hendersonville, North Carolina, 28791

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Wellmont Medical Associates Oncology and Hematology-Johnson City

    Johnson City, Tennessee, 37604

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina, 27284

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Regional Cancer Center at Indian Path Community Hospital

    Kingsport, Tennessee, 37660

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lancaster Radiation Oncology

    Lancaster, Ohio, 43130

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Cone Heath Cancer Center at Mebane

    Mebane, North Carolina, 27302

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Novant Health Cancer Institute - Mount Airy

    Mount Airy, North Carolina, 27030

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Black Hills Obstetrics and Gynecology

    Rapid City, South Dakota, 57701

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Carilion Clinic Gynecological Oncology

    Roanoke, Virginia, 24016

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • University of California San Diego

    San Diego, California, 92103

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • University of Washington Medical Center - Northwest

    Seattle, Washington, 98133

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Novant Health Cancer Institute - Thomasville

    Thomasville, North Carolina, 27360

  • University of Toledo

    Toledo, Ohio, 43614

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Novant Health Cancer Institute - Wilkesboro

    Wilkesboro, North Carolina, 28659

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

  • Winston-Salem Health Care

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: A Phase II Evaluation of Elesclomol Sodium and Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This phase II trial studies how well elesclomol sodium and paclitaxel work in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has returned after a period of improvement (recurrent) or is persistent. Drugs used in chemotherapy, such as elesclomol sodium and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Elesclomol sodium may also help paclitaxel work better by making tumor cells more sensitive to the drug.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the antitumor activity of elesclomol (elesclomol sodium) and paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer primarily through the frequency of objective tumor responses.

II. To determine the nature and degree of toxicity of elesclomol and paclitaxel in this cohort of patients.

SECONDARY OBJECTIVES:

  1. To estimate the progression-free survival and overall survival of patients treated with elesclomol and paclitaxel.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Elesclomol Sodium, Paclitaxel
Medical subject headings
Brenner Tumor, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elesclomol SodiumDrug

    Also called STA-4783

    Given IV

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

Study groups in NCT00888615
Study groupRoleWhat they receive
Treatment (paclitaxel, elesclomol sodium)ExperimentalPatients receive paclitaxel IV over 1 hour and elesclomol sodium IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: Patients who are currently on treatment must not be dosed with elesclomol sodium after 12/31/2015. All other study procedures, with the exception of elesclomol sodium administration and paclitaxel administration, should continue in accordance with protocol requirements. Any treatment given after 12/31/2015, including continuation of paclitaxel, will be considered off study.
Receives: Drug: Elesclomol Sodium; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants With Objective Response

    Proportion of Participants with Object Response (per response evaluation criteria in solid tumors criteria (RECIST V1.1) for target lesions as assessed by MRI: Complete Response (CR), disappearance of all target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 5 years

  2. Duration of Objective Response

    Duration of objective response (months)

    Measured: Up to 5 years

  3. Number of Participants Who Experienced at Least One Adverse Event

    The frequency of patients who experienced at least one adverse effect (with a grade of 1 or higher). Adverse effects are defined as any unfavorable and unintended sign, symptom, or disease that occurs in a patient administered a medical treatment, whether the event is considered related or unrelated to the medical treatment.

    Measured: Up to 5 years

  4. The Number of Participants Who Experienced at Least One Grade 3 Adverse Event

    The number of participants who experienced at least one grade three (or higher) adverse effect. The severity of observed adverse effects is graded using the NCI CTCAE version 4.0.

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Progression-free Survival (Median)

    Progression-free survival (median, in months) will be analyzed by Kaplan-Meier analysis (progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (also a 5 mm absolute increase is also required), or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years

  2. Overall Survival (Median)

    Overall survival (median, in months) will be analyzed by Kaplan-Meier analysis.

    Measured: From start of treatment to time of death or the date of last contact, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2009 (estimated)
  2. Study start13 Dec 2010
  3. Primary completion1 Sep 2011
  4. Study completion31 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00888615
Sponsor's protocol ID
GOG-0260
Other IDs
NCI-2011-01919, CDR0000641202, GOG-0260, GOG-0260, GOG-0260, U10CA180868, U10CA027469
Status last verified
Sep 2021
First submitted
24 Apr 2009
Last updated
20 Oct 2021
Data monitoring committee
Yes

Publications

  • Monk BJ, Kauderer JT, Moxley KM, Bonebrake AJ, Dewdney SB, Secord AA, Ueland FR, Johnston CM, Aghajanian C. A phase II evaluation of elesclomol sodium and weekly paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer: An NRG oncology/gynecologic oncology group study. Gynecol Oncol. 2018 Dec;151(3):422-427. doi: 10.1016/j.ygyno.2018.10.001. Epub 2018 Oct 8.

    PubMed 30309721

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elesclomol Sodium and Paclitaxel in people with Fallopian Tube Clear Cell Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, run by GOG Foundation at 163 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Objective Response (time frame: Up to 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00888615, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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