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Fallopian Tube CancerPhase 3AGO-OVAR9NCT00052468

Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

A Phase 3 study testing TCG and TC in people with Fallopian Tube Cancer and Ovarian Cancer, run by AGO Study Group at 17 sites in 4 countries.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fallopian Tube Cancer, Ovarian Cancer
What is being tested?
TCG and TC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,742 participants
Where
17 sitesin 4 countries
Study dates
Aug 2002to Jan 2011
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of one of the following:
  • Ovarian epithelial cancer
  • FIGO stage IA/B G3, IC-IV
  • Fallopian tube cancer
  • Extra-ovarian papillary serous tumor
  • The following are ineligible:
  • Low malignant-potential ovarian tumors (borderline tumors)
  • Non-epithelial ovarian tumors
  • Mixed Mullerian tumors
  • Must have had definitive surgery within the past 6 weeks
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • WBC at least 3,000/mm^3 OR
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 mg/dL

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal

Renal

  • Glomerular filtration rate at least 50 mL/min

Cardiovascular

  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart disease
  • No prior atrial or ventricular arrhythmias

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior seizures or central nervous system disorder
  • No prior severe hypersensitivity reaction to products containing Cremophor EL (e.g., cyclosporine or vitamin K)
  • No known hypersensitivity to compounds chemically related to carboplatin, gemcitabine, or paclitaxel
  • No preexisting motor or sensory neuropathy greater than grade 1
  • No other malignancy within the past 5 years except:
  • Malignancies cured by surgery alone
  • Carcinoma in situ of the cervix
  • Adequately treated basal cell skin cancer
  • No complete bowel obstruction
  • No other concurrent severe medical condition that would preclude study participation
  • No dementia or significantly altered mental status that would preclude study participation
  • No concurrent severe active infection
  • Geographically accessible for treatment and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except:
  • Hormone replacement therapy
  • Antiemetic steroids

Radiotherapy

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Other

  • No other concurrent antineoplastic agents
  • No other concurrent investigational drugs
  • No other concurrent clinical trial enrollment

Trial locations and contacts

17 sites in 4 countries.

17 sites in 4 countries

Germany14 sites

  • Zentralkrankenhaus

    Bremen, D-28205

  • Evangelisches Krankenhaus

    Düsseldorf, DOH-40217

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Staedtische Kliniken Frankfurt am Main - Hoechst

    Frankfurt, D-65929

  • Frauenklinik der MHH

    Hanover, 30659

  • Vincentius Krankenhaus

    Karlsruhe, D-76137

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, 39108

  • Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

    Munich, D-81377

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster

    Münster, D-48129

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Universitaet Ulm

    Ulm, D-89075

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

Other trials in Germany

Denmark1 site

  • Herlev Hospital - University Hospital of Copenhagen

    Copenhagen, DK2730

Other trials in Denmark

France1 site

  • Hotel Dieu de Paris

    Paris, 75181

Other trials in France

Norway1 site

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

Read the detailed description

OBJECTIVES:

  • Compare overall survival in patients with stage I-IV ovarian epithelial or fallopian tube cancer treated with adjuvant carboplatin and paclitaxel with or without gemcitabine.
  • Compare response rates, progression-free survival, and duration of response in patients treated with these regimens.
  • Compare toxic effects of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to FIGO stage (I-IIA vs IIB-IIIC and tumor no greater than 10 mm vs IIB-IIIC and tumor greater than 10 mm or IV), plan for interval surgical debulking (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive carboplatin IV over 30-60 minutes and paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8.
  • Arm II: Patients receive carboplatin and paclitaxel as in arm I. Treatment in both arms repeats every 21 days for 6 to 10 courses in the absence of disease progression or unacceptable toxicity.

Some patients undergo interval debulking surgery.

Quality of life is assessed at baseline, after courses 3 and 6, and then at 3, 6, and 12 months after completion of study.

Patients are followed every 3 months for 2 years, every 6 months for up to 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,716 patients (858 per treatment arm) will be accrued for this study within 2 years.

Being tested
TCG, TC
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • TCGDrug

    Also called Paclitaxel/Carboplatin/Gemcitabine

  • TCDrug

    Also called Paclitaxel/Carboplatin

Study groups in NCT00052468
Study groupRoleWhat they receive
TCGExperimentalPaclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, Gemcitabine 800 mg/m2 day 1 + 8, q 21 days / 6 - 10 courses
Receives: Drug: TCG
TCActive comparatorPaclitaxel 175 mg/m2 day 1, Carboplatin AUC 5 day 1, q 21 days / 6 - 10 courses
Receives: Drug: TC

What is being measured

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

  1. Overall Survival

    Survival time is calculated from the date of enrollment into the study until the date of death from any cause

    Measured: Whole Study Period

Secondary outcomes (1)

  1. Progression Free Survival

    The progression-free survival is calculated for all patients from the date of enrollment until the date of first progressive disease or death, whichever occurs first

    Measured: Whole Study Period

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionJul 2009
  4. Study completionJan 2011

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
Factorial
Masking
None (open label)
Enrolment
1,742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052468
Sponsor's protocol ID
CDR0000258429
Other IDs
AGO-OVAR9, NORDIC-AGO-OVAR-9, GERCOR-AGO-OVAR-9, EU-20241
Acronym
AGO-OVAR9
Status last verified
Jun 2014
First submitted
24 Jan 2003
Last updated
25 Jun 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • du Bois A, Herrstedt J, Hardy-Bessard AC, Muller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.

    PubMed 20733132

  • Machelon V, Gaudin F, Camilleri-Broet S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prevot S, Broet P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.

    PubMed 21410972

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TCG and TC in people with Fallopian Tube Cancer and Ovarian Cancer, run by AGO Study Group at 17 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?

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 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Germany, Denmark, France, Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (time frame: Whole Study Period). 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 NCT00052468, 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 25 Jun 2014.

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