Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer

Brief Title

Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer

Official Title

A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma

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 combination chemotherapy consisting of
      liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated
      ovarian, peritoneal, or fallopian tube cancer.

Detailed Description

      OBJECTIVES:

        -  Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with
           paclitaxel and carboplatin in patients with previously untreated ovarian epithelial,
           peritoneal, or fallopian tube cancer.

        -  Determine the toxicity of this treatment regimen in these patients.

        -  Evaluate measurable disease in patients treated with this regimen.

      OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox).

      Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and
      paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days
      for 4 courses in the absence of unacceptable toxicity or disease progression.

      Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity. An additional cohort of 12 patients receives
      LipoDox at the MTD with carboplatin and paclitaxel as above.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.

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

Estimated Enrollment

Start Date

March 1999

Primary Completion Date

January 2007

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal
             carcinoma, or fallopian tube carcinoma

          -  The following histologic epithelial cell types are eligible:

               -  Serous adenocarcinoma

               -  Endometrioid adenocarcinoma

               -  Mucinous adenocarcinoma

               -  Undifferentiated carcinoma

               -  Clear cell adenocarcinoma

               -  Mixed epithelial carcinoma

               -  Transitional cell

               -  Malignant Brenner tumor

               -  Adenocarcinoma not otherwise specified

          -  No more than 12 weeks since diagnosis

          -  No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)

        PATIENT CHARACTERISTICS:

        Age:

          -  Not specified

        Performance status:

          -  GOG 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC at least 3,000/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Absolute granulocyte count at least 1,500/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.5 times normal

          -  SGOT/SGPT no greater than 3 times normal

          -  Alkaline phosphatase no greater than 3 times normal

          -  Gamma-glutamyl-transferase no greater than 3 times normal

          -  No acute hepatitis

        Renal:

          -  Creatinine no greater than 2.0 mg/dL OR

          -  Creatinine clearance greater than 50 mL/min

        Cardiovascular:

          -  LVEF normal by MUGA

          -  No unstable angina

          -  No myocardial infarction within the past 6 months

          -  Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block)
             are eligible if disease has been stable for the past 6 months

        Other:

          -  No septicemia or severe infection

          -  No severe gastrointestinal bleeding

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy

        Surgery:

          -  Recovered from recent prior surgery

        Other:

          -  No prior anticancer therapy that would preclude study

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Peter G. Rose, MD, ,

Location Countries

Norway

Location Countries

Norway

Administrative Informations

NCT ID

NCT00003385

Organization ID

CDR0000066381

Secondary IDs

GOG-9703

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Peter G. Rose, MD, Study Chair, MetroHealth Cancer Care Center at MetroHealth Medical Center

Verification Date

September 2003