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Ovarian CancerPhase 3NCT00102375

Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

A Phase 3 study testing Topotecan in people with Ovarian Cancer, run by AGO Study Group at 18 sites in Germany.

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

The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Topotecan
How many people
900 participants
Where
18 sitesGermany
Study dates
Dec 1999to Oct 2004
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

  • Histologically proven epithelial carcinoma of the ovary or of the fallopian tube or extraovarian papillary serous carcinoma with extent to the ovary
  • International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IV, regardless of measurable or non-measurable disease
  • No prior chemo- or radiotherapy
  • Adequate hematologic, renal and hepatic function:
  • ANC ≥ 1.5 x 10^9/L,
  • Platelet counts ≥ 100 x 10^9/L,
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  • Total bilirubin ≤ 1.5 x upper normal limit,
  • Alkaline Phosphatase ≤ 3 x upper normal limit,
  • Serum creatinine ≤ 1.25 upper normal limit,
  • Estimated GFR ≥ 60 ml/min
  • Performance status 0-2 (ECOG)
  • Life expectancy must be greater than 12 weeks

Who cannot join

  • Non-epithelial tumors or mixed epithelial/non-epithelial tumors (e.g. mixed Mullerian tumors) or tumors of low malignant potential (borderline tumors)
  • Prior treatment with chemo- or radiotherapy
  • Administration of other simultaneous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy
  • History of congestive heart failure
  • Symptomatic brain metastasis
  • Complete bowel obstruction
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  • Dementia
  • Active infection or other serious underlying medical condition
  • Pre-existing motor or sensory neurologic pathology

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Gynecologic Hospital of the Medical Facilities RWTH

    Aachen, 52074

  • Clinic for Gynecology and Gyn. Oncology, Humboldt University

    Berlin, 10117

  • University Clinic Carl Gustav Carus, Gynecological hospital

    Dresden, 01307

  • Gynecologic Hospital

    Düsseldorf, 40217

  • University Gynecologic Hospital

    Düsseldorf, 40225

  • University Gynecologic Hospital

    Frankfurt, 60596

  • University Gynecologic Hospital

    Göttingen, 37075

  • Gynecologic Clinic of the Ernst-Moritz-Arndt-University

    Greifswald, 17487

  • Gynecological Clinic of the Medical University

    Hanover, 30659

  • St. Vincentius Gynecologic Hospital

    Karlsruhe, 76137

  • University Clinic Schleswig-Holstein, Campus Kiel, Clinic for gynecology and obstetrics

    Kiel, 24105

  • Otto-von-Guericke University, University Gynecological Hospital

    Magdeburg, 39108

  • University Gynecologic Hospital Grosshadern

    München, 81377

  • University Gynecologic Hospital "rechts der Isar"

    München, 81675

  • Clinic for Gynecology

    Münster, 48149

  • University Gynecologic Hospital

    Tübingen, 72076

  • University Gynecological Hospital

    Ulm, 89075

  • Clinic for Gnyecology and gyn. Oncology HSK

    Wiesbaden, 65199

Other trials in Germany

About this study

Official title: Phase III Multicenter Study in Epithelial Ovarian Carcinoma FIGO Stage IIB-IV Comparing Treatment With Paclitaxel and Carboplatin to Paclitaxel and Carboplatin Sequentially Followed by Topotecan

The purpose of this study is to determine whether the triple combination of Carboplatin, Paclitaxel and Topotecan has a superior clinical outcome in the treatment of ovarian cancer compared with the combination of Carboplatin and Paclitaxel.

Read the detailed description

Carboplatin-Paclitaxel is the current standard in the first-line treatment of advanced ovarian cancer. One option to further improve the therapeutic results is the incorporation of a third, non-cross-resistant drug into first line chemotherapy of advanced ovarian cancer. In two separate, single center phase II studies, a different combination of the three active agents (Carboplatin, Paclitaxel and Topotecan) has been tested. In these studies, Carboplatin and Paclitaxel were given at standard doses and schedules, followed sequentially by Topotecan which was well tolerated at a dose of 1.25 mg/m2/day given for five days and repeated every 21 days. The prolonged therapy is not associated with cumulative toxicity and the compliance of the patients was good.

Study Hypothesis/Comparison: The triple combination (Carboplatin/Paclitaxel/Topotecan) yields superior outcome in the treatment of first-line ovarian cancer compared with the combination of Carboplatin + Paclitaxel

Conditions
Ovarian Cancer
Being tested
Topotecan
Keywords
Ovarian Cancer, first-line, Topotecan
Medical subject headings
Ovarian Neoplasms

What participants receive

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

What is being measured

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

  1. Survival

Secondary outcomes (5)

  1. Progression-free survival

  2. Response rate

  3. Response duration

  4. Toxicities

  5. Quality of Life

Timeline

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

  1. First posted31 Jan 2005 (estimated)
  2. Study startDec 1999
  3. Study completionOct 2004

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
Single group
Masking
None (open label)
Enrolment
900 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102375
Sponsor's protocol ID
AGO-OVAR 7
Status last verified
Feb 2006
First submitted
29 Jan 2005
Last updated
4 Aug 2006
Results posted
No

Publications

  • Pfisterer J, Weber B, Reuss A, Kimmig R, du Bois A, Wagner U, Bourgeois H, Meier W, Costa S, Blohmer JU, Lortholary A, Olbricht S, Stahle A, Jackisch C, Hardy-Bessard AC, Mobus V, Quaas J, Richter B, Schroder W, Geay JF, Luck HJ, Kuhn W, Meden H, Nitz U, Pujade-Lauraine E; AGO-OVAR; GINECO. Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: a gynecologic cancer intergroup trial of the AGO-OVAR and GINECO. J Natl Cancer Inst. 2006 Aug 2;98(15):1036-45. doi: 10.1093/jnci/djj296.

    PubMed 16882940

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Topotecan in people with Ovarian Cancer, run by AGO Study Group at 18 sites in Germany.

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 12 inclusion and 9 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 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. 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?

Survival. 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 NCT00102375, 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 4 Aug 2006.

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