Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Brief Title

Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Official Title

A Phase I Trial of Combination Carboplatin and Lipsomal Doxorubicin (Doxil) In Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

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 trial to study the effectiveness of combining liposomal doxorubicin and
      carboplatin in treating patients who have recurrent ovarian, fallopian tube, or primary
      peritoneal cancer.

Detailed Description

      OBJECTIVES: I. Determine the maximum tolerated dose of doxorubicin HCl liposome (Doxil) when
      combined with carboplatin in patients with recurrent ovarian, fallopian tube, or primary
      peritoneal cancer. II. Determine the toxicity of this regimen in these patients. III.
      Determine the rate of response in patients treated with this regimen.

      OUTLINE: This is a dose escalation, multicenter study of doxorubicin HCl liposome (Doxil).
      Patients receive Doxil IV over 1 hour and carboplatin IV on day 1. Treatment continues every
      4 weeks for a minimum of 6 courses in the absence of unacceptable toxicity or disease
      progression. Cohorts of 3-6 patients receive escalating doses of Doxil until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which 0 or 1 of
      6 patients experience dose limiting toxicity. Patients are followed every 3 months for 2
      years, then every 6 months for 3 years, and then annually thereafter until recurrence or
      death.

      PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study over 1 year.

Study Phase

Phase 1

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

carboplatin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Primary Completion Date

February 2006

Eligibility Criteria

        DISEASE CHARACTERISTICS: Histologically proven recurrent ovarian, tubal, or peritoneal
        cancer that is platinum sensitive (i.e., 6 months from last chemotherapy) Maximum of 1
        prior chemotherapy regimen comprised of no more than 6 treatments at first recurrence Must
        have 1 of the following epithelial subtypes: Serous adenocarcinoma Endometrioid
        adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma
        Mixed epithelial carcinoma Transitional cell Malignant Brenner tumor Adenocarcinoma not
        otherwise specified Measurable or evaluable disease Greater than 2 cm by CT scan, if
        measurable

        PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy:
        Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
        least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin normal SGOT,
        SGPT, GGT, and alkaline phosphatase no greater than 2.5 times upper limit of normal No
        acute hepatitis Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF
        normal by MUGA No congestive heart failure No unstable angina No myocardial infarction
        within the past 6 months Abnormal cardiac conduction (e.g., bundle branch block, heart
        block) allowed if disease has been stable for at least 6 months Other: No septicemia or
        significant infection No severe gastrointestinal bleeding No other malignancy within the
        past 5 years except nonmelanomatous skin cancer

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
        Characteristics No prior anthracycline therapy At least 3 weeks since other prior
        chemotherapy for ovarian, fallopian tube, or peritoneal cancer and recovered Endocrine
        therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: At least 3 weeks since
        prior surgery for ovarian, fallopian tube, or peritoneal cancer and recovered Other: No
        other prior cancer therapy that would preclude study therapy

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Rodriguez, MD, ,

Administrative Informations

NCT ID

NCT00006235

Organization ID

CDR0000068160

Secondary IDs

GOG-9909

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Michael Rodriguez, MD, Study Chair, University Hospitals Seidman Cancer Center

Verification Date

February 2006