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Ovarian NeoplasmsPhase 3ASSIST-5NCT00350948

Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

A Phase 3 study testing Telcyta and Liposomal Doxorubicin in people with Ovarian Neoplasms, run by Telik at 71 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms
What is being tested?
Telcyta and Liposomal Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
71 sitesin 4 countries
Study dates
May 2006to Dec 2008
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Are a woman 18 years of age or older
  • Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
  • Have platinum refractory or resistant cancer
  • Measurable disease according to radiographic RECIST criteria progression

Who cannot join

  • Had treatment with first-line chemotherapy other than a platinum-containing regimen
  • Have clinically significant cardiac disease
  • Have any sign of intestinal obstruction interfering with nutrition
  • Are pregnant or lactating
  • Had prior treatment with liposomal doxorubicin
  • Had prior treatment with Telcyta

Trial locations and contacts

71 sites in 4 countries.

71 sites in 4 countries

United States63 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • East Bay Medical Oncology/Hematology Medical Associates, Inc.

    Antioch, California, 94509

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28816

  • Schwaartz Gynecologic Oncology, PLLC

    Babylon, New York, 11702

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Desert Oasis Cancer Center

    Casa Grande, Arizona, 85222

  • Carolina Center of Gynecologic Oncology

    Charleston, South Carolina, 29407

  • Blumenthal Cancer Center

    Charlotte, North Carolina, 28204

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Palmetto Health Alliance-Richland

    Columbia, South Carolina, 29210

  • South Carolina Oncology Associates

    Columbia, South Carolina, 29210

  • Gynecologic Oncology & Pelvic Surgery Associates

    Columbus, Ohio, 43222

  • Bay Area Cancer Research Group, LLC

    Concord, California, 94520

  • East Bay Medical Oncology/Hematology Medical Associates

    Concord, California, 94520

  • The Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Danville Hematology & Oncology, Inc.

    Danville, Virginia, 24541

  • Hematology & Oncology Associates of NEPA

    Dunmore, Pennsylvania, 18512

  • Dakota Cancer Institute/Dakota Clinic Ltd.

    Fargo, North Dakota, 58103

  • Flossmoor Cancer Care (JOHA DBA)

    Flossmoor, Illinois, 60422

  • California Oncology of the Central Valley

    Fresno, California, 93710

  • Gynecologic Oncology Associates, Inc

    Hollywood, Florida, 33020

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • Shands Jacksonville Medical Center

    Jacksonville, Florida, 32209

  • University of Florida College of Medicine-Jacksonville

    Jacksonville, Florida, 32209

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois, 60432

  • Joliet Oncology-Hematology Associates, LTD.

    Joliet, Illinois, 60435

  • Kankakee Cancer Center (JOHA DBA)

    Kankakee, Illinois, 60901

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Piedmont Hematology Oncology Associates-Lexington Satellite

    Lexington, North Carolina, 27292

  • Hematology Oncology Services of Arkansas

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Hematology and Oncology Specialists, LLC

    Metairie, Louisiana, 70006

  • Joliet Oncology-Hematology Associates

    Morris, Illinois, 60450

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Women's Cancer Research Foundation

    Newport Beach, California, 92663

  • Hematology & Oncology Consultants P.C.

    Omaha, Nebraska, 68122

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Florida Hospital

    Orlando, Florida, 32804

  • Gynecologic Oncology Associates, Inc

    Pembroke Pines, Florida, 33028

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Kaiser Permanente NW, Oncology/Hematology

    Portland, Oregon, 97227

  • Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Southwest Cancer Care

    Poway, California, 92064

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California, 92270

  • Carilion GYN Oncology Associates

    Roanoke, Virginia, 24014

  • Southern California Permanente Medical Group

    San Diego, California, 92120

  • East Bay Medical Oncoogy/Hematology Medical Associates, Inc.

    San Leandro, California, 94578

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Horizon's West Medical Group

    Scottsbluff, Nebraska, 69361

  • The Women's Center of Western Nebraska

    Scottsbluff, Nebraska, 69361

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Arch Medical Services

    St Louis, Missouri, 63141

  • Garth Phibbs, M.D., FACOG

    Toledo, Ohio, 43606

  • The Toledo Hospital

    Toledo, Ohio, 43606

  • Arlington Cancer Center

    Trophy Club, Texas, 76262

  • Associates in Hematolog-Oncology, P.C.

    Upland, Pennsylvania, 19013

  • Diablo Valley Oncology & Hematology Medical Group, Inc.

    Walnut Creek, California, 94598

  • Piedmont Hematology Oncology Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Belgium3 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, B-2020

  • A.Z. Groeninge Oncologish Centrum

    Kortrijk, B-8500

  • Universitaire Ziekenhuizen Leuven Dienst Oncologie

    Leuven, B3000

Other trials in Belgium

Brazil3 sites

  • Hospital Vera Cruz-Instituto de Oncologia

    Belo Horizonte, Minas Gerais, 30190-130

  • Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    Cerqueria Cesar, São Paulo, 05403-010

  • Fundacao Hospital Amaral Carvalho

    Rua Dona Siilveria, São Paulo, 17210-080

Other trials in Brazil

United Kingdom2 sites

  • Ninewells Hospital and Medical School

    Dundee, Scotland, DD1 9SY

  • Guy's & St. Thomas Cancer Centre

    London, England, SE19RT

Other trials in United Kingdom

About this study

Official title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

Read the detailed description

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Being tested
Telcyta, Liposomal Doxorubicin
Keywords
Ovary
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • TelcytaDrug

    Also called TLK286, canfosfamide

    Day 1 of 28 day Cycle.

  • Liposomal DoxorubicinDrug

    Also called Doxil, Caelyx

    Day 1 of 28 Day Cycle. 50 mg/m2

Study groups in NCT00350948
Study groupRoleWhat they receive
Telcyta + Liposomal DoxorubicinExperimentalTelcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Receives: Drug: Telcyta; Drug: Liposomal Doxorubicin
Liposomal DoxorubicinActive comparatorLiposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Receives: Drug: Liposomal Doxorubicin

What is being measured

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

  1. To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin

    Measured: Once 244 planned pts. received at least 2 cycles of study treatment(s)

Secondary outcomes (1)

  1. To evaluate and compare the safety profile of each treatment arm

    Measured: Any patient who received 1 dose of study treatment(s) will be evaluable for safety.

Timeline

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

  1. First posted11 Jul 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionDec 2008
  4. Study completionDec 2008

Why it stopped: Business reasons

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00350948
Sponsor's protocol ID
TLK286.3025
Acronym
ASSIST-5
Status last verified
Nov 2013
First submitted
6 Jul 2006
Last updated
27 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.

    PubMed 37407274

  • Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.

    PubMed 20973267

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telcyta and Liposomal Doxorubicin in people with Ovarian Neoplasms, run by Telik at 71 sites in 4 countries.

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 4 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: stopped early, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Belgium, Brazil, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: Business reasons). Results are not available in the source record.

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?

To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (time frame: Once 244 planned pts. received at least 2 cycles of study treatment(s)). 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 NCT00350948, which also lists 2 linked publications.

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 27 Nov 2013.

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