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Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
doxorubicin hydrochloride
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, ovarian sarcoma, recurrent ovarian germ cell tumor, ovarian stromal cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

Sites / Locations

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Outcomes

Primary Outcome Measures

Acute toxicity
Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
Primary efficacy and safety (phase II)

Secondary Outcome Measures

Full Information

First Posted
November 20, 2007
Last Updated
November 16, 2017
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Ortho Biotech Clinical Affairs, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00562185
Brief Title
Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer
Official Title
A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Funding source withdrew funding
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Ortho Biotech Clinical Affairs, L.L.C.

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary 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. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer, ovarian sarcoma, recurrent ovarian germ cell tumor, ovarian stromal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Primary Outcome Measure Information:
Title
Acute toxicity
Title
Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I)
Title
Primary efficacy and safety (phase II)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: 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 PRIOR CONCURRENT THERAPY: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayanthi S. Lea, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer

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