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Trial record 41 of 57 for:    "Germ Cells Tumors" | "Carboplatin"

Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian 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: NCT00562185
Recruitment Status : Withdrawn (Funding source withdrew funding)
First Posted : November 21, 2007
Last Update Posted : November 20, 2017
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as doxorubicin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving doxorubicin together with carboplatin may kill more tumor cells.

PURPOSE: This phase I and phase II trial is studying the side effects and best dose of carboplatin when given together with doxorubicin to see how well it works in treating patients with recurrent ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: carboplatin Drug: doxorubicin hydrochloride Phase 1 Phase 2

Detailed Description:



  • To determine the maximum tolerated dose and safety of intravenous doxorubicin hydrochloride and intraperitoneal carboplatin in patients with platinum-sensitive recurrent ovarian cancer.
  • To evaluate the feasibility of this regimen in these patients.


  • To evaluate the response rate and progression-free survival of patients with recurrent ovarian cancer who have had no more than two prior salvage regimens.

OUTLINE: This is a phase I dose-escalation study of carboplatin followed by a phase II study.

  • Phase I: Patients receive doxorubicin hydrochloride IV over 1 hour followed by carboplatin intraperitoneally on day 1 until the maximum tolerated dose is achieved. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
  • Phase II: Patients receive doxorubicin hydrochloride as in phase I and carboplatin at the maximum tolerated dose as in phase I.

After completion of study treatment, patients are followed every 4 weeks for 1 year.

PROJECTED ACCRUAL: A total of 61 patients (18 patients in phase I and 43 patients in phase II) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Primary Outcome Measures :
  1. Acute toxicity
  2. Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
  3. Primary efficacy and safety (phase II)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian carcinoma

    • Recurrent disease
  • Known platinum-sensitive recurrent disease after no more than 2 prior salvage regimens
  • Measurable disease as defined by a target lesion and a CA125 level
  • No epithelial ovarian carcinoma of low malignant potential


Inclusion criteria:

  • GOG performance status 0, 1, or 2
  • Life expectancy > 6 months
  • Absolute neutrophil count ≥ 1,500/uL
  • Platelet count ≥ 100,000/uL
  • Hemoglobin > 9.0 g/dL
  • Creatinine ≤ 2.0 mg/dL
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • SGOT and alkaline phosphatase ≤ 3 x ULN
  • Neuropathy (sensory and motor) ≤ CTCAE grade 1

Exclusion criteria:

  • GOG performance status 3 or 4
  • Pregnant or breastfeeding
  • History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin hydrochloride or the components of DOXIL®
  • Abnormal LVEF as determined by gated cardiac radionucleotide scan (MUGA)
  • Septicemia or severe infection
  • Acute hepatitis or severe gastrointestinal bleeding
  • Any of the following:

    • Unstable angina
    • Myocardial infarction within the past 6 months
    • NYHA class II-IV heart failure
    • Uncontrolled angina
    • Severe uncontrolled ventricular arrhythmias
    • Clinically significant pericardial disease
    • Electrocardiographic evidence of acute ischemic or active conduction system abnormalities

      • Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if their disease has been stable for the past six months
  • Other invasive malignancies within the past 5 years except for nonmelanoma skin cancer


Inclusion criteria:

  • See Disease Characteristics
  • At least 6 months since prior adjuvant regimen
  • At least 4 weeks since prior salvage treatment
  • May have received secondary cytoreduction for recurrent ovarian cancer
  • May have received prior intraperitoneal therapy for ovarian cancer
  • May have received no more than 2 prior platinum and taxane-based regimens
  • May have received prior intraperitoneal platinum during front-line treatment

Exclusion criteria:

  • Prior anthracycline dose exceeding 360 mg/m^2 for doxorubicin hydrochloride (including DOXIL®) or 720 mg/m^2 for epirubicin hydrochloride
  • Prior radiotherapy
  • Prior intraperitoneal carboplatin or cisplatin as salvage treatment for recurrent ovarian cancer
  • Concurrent amifostine or other protective agents

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): NCT00562185

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United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Ortho Biotech Clinical Affairs, L.L.C.
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Study Chair: Jayanthi S. Lea, MD Simmons Cancer Center

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Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT00562185     History of Changes
Other Study ID Numbers: CDR0000574034
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: October 2017
Keywords provided by University of Texas Southwestern Medical Center:
recurrent ovarian epithelial cancer
ovarian sarcoma
recurrent ovarian germ cell tumor
ovarian stromal cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action