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Fallopian Tube CancerPhase 2NCT00031954

Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

A Phase 2 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Fallopian Tube Cancer and 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

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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or… Read more about this study

Who is it for?
Ages 18 to 120 years, women only
What is being tested?
carboplatin, gemcitabine hydrochloride and paclitaxel
How many people
105 participants
Where
18 sitesGermany
Study dates
Aug 2001to Apr 2004
Phase
Phase 2
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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma
  • No tumors of low-malignant potential (borderline tumors)
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 6 months

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal

Renal:

  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled
  • No myocardial infarction within the past 6 months
  • No history of atrial or ventricular arrhythmias

Neurologic:

  • No history of seizure disorder
  • No history of CNS disorder
  • No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater

Other:

  • No severe concurrent infection
  • No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine
  • No complete bowel obstruction
  • No other concurrent severe medical problems that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy
  • No concurrent WBC transfusions

Chemotherapy:

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except replacement therapy or steroid antiemetics

Radiotherapy:

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • No more than 6 weeks since prior definitive surgery

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Germany18 sites

  • Universitaetsklinikum Charite

    Berlin, D-10117

  • Zentralkrankenhaus

    Bremen, D-28205

  • Medizinische Klinik I

    Dresden, D-01307

  • Evangelisches Krankenhaus

    Düsseldorf, DOH-4-0217

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Staedtisches Krankenhaus FFM-Hoechst

    Frankfurt am Main, 65929

  • Universitaetsklinik Goettingen

    Göttingen, D-37075

  • Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17487

  • Frauenklinik der MHH

    Hanover, 30659

  • Vincentius Krankenhaus

    Karlsruhe, D-76137

  • Christian-Albrechts University of Kiel

    Kiel, D-24105

  • Klinik der Otto-v.-Guericke-Universitat

    Magdeburg, 39108

  • Klinikum Grosshadern

    Munich (Muenchen), D-81377

  • Klinikum Rechts Der Isar/Technische Universitaet Muenchen

    Munich (Muenchen), D-81675

  • Klinik und Poliklinik fuer Kinderheilkunde

    Münster, D-48129

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Universitaet Ulm

    Ulm, D-89075

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

Other trials in Germany

About this study

Official title: A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.

Read the detailed description

OBJECTIVES:

  • Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma.
  • Determine the response rate of patients treated with this regimen.
  • Determine the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Keywords
stage II ovarian epithelial cancer, stage I ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity 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.

What is being measured

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

  1. Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity

    The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05

    Measured: Based on decision level

Timeline

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

  1. First posted1 Jul 2003 (estimated)
  2. Study startAug 2001
  3. Primary completionApr 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00031954
Sponsor's protocol ID
AGO-OVAR 8
Other IDs
AGOSG-OVAR-8, EU-20146
Status last verified
Dec 2015
First submitted
8 Mar 2002
Last updated
23 Dec 2015
Results posted
No

Publications

  • du Bois A, Belau A, Wagner U, Pfisterer J, Schmalfeldt B, Richter B, Staehle A, Jackisch C, Lueck HJ, Schroeder W, Burges A, Olbricht S, Elser G; Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR). A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8). Gynecol Oncol. 2005 Feb;96(2):444-51. doi: 10.1016/j.ygyno.2004.10.020.

    PubMed 15661234

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Fallopian Tube Cancer and 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?

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 23 Dec 2015. 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 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?

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?

Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity (time frame: Based on decision level). 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 NCT00031954, 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 23 Dec 2015.

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