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AzTrials

Cervical CancerPhase 1/2NCT00032162

Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

A Phase 1/2 study testing carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Cervical Cancer and Endometrial Cancer, run by AGO Study Group at 19 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 I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
carboplatin and pegylated liposomal doxorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
19 sitesGermany
Study dates
Aug 2001to May 2005
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer
  • No ovarian epithelial cancer

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin greater than 10.0 g/dL

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal

Renal:

  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

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

Other:

  • No pre-existing sensory or motor neuropathy grade 2 or greater
  • No active infection
  • No other serious medical condition that would preclude study
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • No more than 1 prior chemotherapy regimen for the malignancy
  • No other concurrent chemotherapy

Endocrine therapy:

  • Prior hormonal therapy within the past 10 days allowed
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow

Surgery:

  • Not specified

Other:

  • At least 30 days since prior experimental agents
  • No other concurrent therapies that would preclude study
  • No concurrent participation in another study

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Germany19 sites

  • Universitaetsklinikum Charite

    Berlin, D-10117

  • Zentralkrankenhaus

    Bremen, D-28205

  • Medizinische Klinik I

    Dresden, D-01307

  • Universitaetsklinik Duesseldorf

    Düsseldorf, D-40225

  • Evangelisches Krankenhaus

    Düsseldorf, DOH-40217

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, 60596

  • 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. Hors t- Schmidt - Kliniken

    Wiesbaden, D-65199

Other trials in Germany

About this study

Official title: Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors

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 I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors.
  • Determine the dose-limiting toxicity of this regimen in these patients.
  • Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome.

Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses.

Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above.

Patients are followed at 4-6 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.

Being tested
carboplatin, pegylated liposomal doxorubicin hydrochloride
Keywords
stage III cervical cancer, recurrent cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IA cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, stage I endometrial carcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma, fallopian tube cancer, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Sarcoma

What participants receive

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

  • carboplatinDrug

    AUC 6 q4w

  • pegylated liposomal doxorubicin hydrochlorideDrug

    20/30/40 mg/qm q4w Dose finding study

Study groups in NCT00032162
Study groupRoleWhat they receive
PLDExperimentaldose finding study of PLD in combination with Carboplatin
Receives: Drug: carboplatin; Drug: pegylated liposomal doxorubicin hydrochloride

What is being measured

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

  1. DL DLT

    Measured: DLT during first 3 cycles

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 2001
  3. Primary completionMay 2005

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00032162
Sponsor's protocol ID
CDR0000069262
Other IDs
AGOSG-AGO-GYN-2, EU-20147
Status last verified
May 2012
First submitted
8 Mar 2002
Last updated
31 May 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • du Bois A, Pfisterer J, Burchardi N, Loibl S, Huober J, Wimberger P, Burges A, Stahle A, Jackisch C, Kolbl H; Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom; Kommission Uterus. Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut). Gynecol Oncol. 2007 Dec;107(3):518-25. doi: 10.1016/j.ygyno.2007.08.008. Epub 2007 Oct 25.

    PubMed 17910981

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carboplatin and pegylated liposomal doxorubicin hydrochloride in people with Cervical Cancer and Endometrial Cancer, run by AGO Study Group at 19 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 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

DL DLT (time frame: DLT during first 3 cycles). 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 NCT00032162, 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 31 May 2012.

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