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

Brief Title

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

Official Title

A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV

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 II trial to study the effectiveness of combination chemotherapy in treating
      patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian
      tube, or peritoneal cancer that has not been previously treated.

Detailed Description

      OBJECTIVES:

        -  Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in
           patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or
           peritoneal carcinoma.

        -  Determine the response rate of patients treated with this regimen.

        -  Determine the time to progression and overall survival of patients treated with this
           regimen.

      OUTLINE: This is a multicenter study.

      Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and
      gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed at 3 and 6 months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity

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

August 2001

Primary Completion Date

April 2004

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal
             carcinoma

               -  No tumors of low-malignant potential (borderline tumors)

          -  No symptomatic brain metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  ECOG 0-2 OR

          -  Karnofsky 70-100%

        Life expectancy:

          -  At least 6 months

        Hematopoietic:

          -  WBC at least 3,000/mm^3

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

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

          -  Hemoglobin greater than 10 g/dL

        Hepatic:

          -  Bilirubin no greater than 2 times upper limit of normal

        Renal:

          -  Glomerular filtration rate at least 60 mL/min

        Cardiovascular:

          -  No history of congestive heart failure (New York Heart Association class III or IV
             heart disease) even if medically controlled

          -  No myocardial infarction within the past 6 months

          -  No history of atrial or ventricular arrhythmias

        Neurologic:

          -  No history of seizure disorder

          -  No history of CNS disorder

          -  No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater

        Other:

          -  No severe concurrent infection

          -  No prior hypersensitivity reaction to products containing Cremophor EL or compounds
             chemically related to carboplatin, paclitaxel, or gemcitabine

          -  No complete bowel obstruction

          -  No other concurrent severe medical problems that would preclude study

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent immunotherapy

          -  No concurrent WBC transfusions

        Chemotherapy:

          -  No prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  No concurrent hormonal therapy except replacement therapy or steroid antiemetics

        Radiotherapy:

          -  No prior radiotherapy

          -  No concurrent radiotherapy

        Surgery:

          -  No more than 6 weeks since prior definitive surgery

Gender

Female

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Andreas du Bois, MD, PhD, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00031954

Organization ID

AGO-OVAR 8

Secondary IDs

AGOSG-OVAR-8

Responsible Party

Sponsor

Study Sponsor

AGO Study Group

Study Sponsor

Andreas du Bois, MD, PhD, Study Chair, Dr. Horst-Schmidt-Kliniken

Verification Date

December 2015