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Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00562185
First received: November 20, 2007
Last updated: March 19, 2009
Last verified: March 2009
  Purpose

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 Intervention Phase
Ovarian Cancer
Drug: carboplatin
Drug: doxorubicin hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Acute toxicity [ Designated as safety issue: Yes ]
  • Maximum tolerated dose of intraperitoneal carboplatin when given in combination with IV doxorubicin hydrochloride (phase I) [ Designated as safety issue: Yes ]
  • Primary efficacy and safety (phase II) [ Designated as safety issue: Yes ]

Estimated Enrollment: 61
Study Start Date: May 2008
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562185

Locations
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Simmons Cancer Center
Investigators
Study Chair: Jayanthi S. Lea, MD Simmons Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: David Scott Miller, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
ClinicalTrials.gov Identifier: NCT00562185     History of Changes
Other Study ID Numbers: CDR0000574034, SCCC-04E07, SCCC-062007-043, ORTHO-SCCC-04E07
Study First Received: November 20, 2007
Last Updated: March 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
ovarian sarcoma
recurrent ovarian germ cell tumor
ovarian stromal cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014