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Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00032162
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 31, 2012
Information provided by (Responsible Party):
AGO Study Group

Brief 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 gynecologic cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Drug: carboplatin Drug: pegylated liposomal doxorubicin hydrochloride Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors
Study Start Date : August 2001
Actual Primary Completion Date : May 2005

Arm Intervention/treatment
Experimental: PLD
dose finding study of PLD in combination with Carboplatin
Drug: carboplatin
AUC 6 q4w

Drug: pegylated liposomal doxorubicin hydrochloride
20/30/40 mg/qm q4w Dose finding study

Primary Outcome Measures :
  1. DL DLT [ Time Frame: DLT during first 3 cycles ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


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


  • Bilirubin no greater than 1.25 times upper limit of normal


  • Glomerular filtration rate at least 60 mL/min


  • 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


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy


  • 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


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


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00032162

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Sponsors and Collaborators
AGO Study Group
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Study Chair: Andreas du Bois, MD, PhD Dr. Horst-Schmidt-Kliniken

Publications of Results:
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Responsible Party: AGO Study Group Identifier: NCT00032162    
Other Study ID Numbers: CDR0000069262
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012
Keywords provided by AGO Study Group:
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
ovarian carcinosarcoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Endometrial Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action