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A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Ovarian Cancer

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Trial Information

A Phase I/II Study of Intravenous Doxil and Intraperitoneal Carboplatin as Salvage Therapy in Patients With Recurrent Ovarian Cancer



- 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

- 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.

Inclusion Criteria


- Histologically confirmed ovarian carcinoma

- Recurrent disease

- Known platinum-sensitive recurrent disease after no more than 2 prior salvage

- 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

- 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


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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute toxicity

Safety Issue:


Principal Investigator

Jayanthi S. Lea, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2008

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • ovarian sarcoma
  • recurrent ovarian germ cell tumor
  • ovarian stromal cancer
  • Ovarian Neoplasms



Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390