Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Brief Title

Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Official Title

A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian 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 oxaliplatin with topotecan in
      treating patients who have previously treated ovarian epithelial, primary peritoneal, or
      fallopian tube cancer.

Detailed Description

      OBJECTIVES:

        -  Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and
           topotecan in patients with previously treated ovarian epithelial cancer, primary
           peritoneal cancer, or fallopian tube cancer.

        -  Determine the qualitative and quantitative toxic effects of this regimen in these
           patients.

        -  Determine the pharmacokinetics of this regimen in these patients.

        -  Determine the antitumor activity of this treatment regimen in these patients.

        -  Determine the correlation between the pharmacokinetic and safety data of this regimen in
           these patients.

      OUTLINE: This is a dose-escalation, multicenter study.

      Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously
      on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease
      progression or unacceptable toxicity. Patients with measurable disease who achieve a response
      may receive additional therapy at the discretion of the principal investigator.

      Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the
      maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6
      patients experience dose-limiting toxicity.

      Patients are followed through day 30.

      PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

Study Phase

Phase 1

Study Type

Interventional

Condition

Fallopian Tube Cancer

Intervention

oxaliplatin

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

Start Date

August 2000

Primary Completion Date

November 2004

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed ovarian epithelial cancer, primary
             peritoneal cancer, or fallopian tube cancer

               -  Prior chemotherapy required

          -  Measurable or evaluable disease

          -  No symptomatic, untreated brain metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 70-100%

        Life expectancy:

          -  At least 4 months

        Hematopoietic:

          -  WBC greater than 3,000/mm^3

          -  Absolute neutrophil count greater than 1,500/mm^3

          -  Platelet count greater than 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR

          -  SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases)

        Renal:

          -  Creatinine no greater than 1.5 times ULN OR

          -  Creatinine clearance at least 50 mL/min

        Cardiovascular:

          -  No uncontrolled symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No uncontrolled cardiac arrhythmia

        Other:

          -  No other active cancer

          -  No prior allergy to platinum compounds

          -  No prior allergic reactions to appropriate antiemetics (e.g., serotonin or
             antagonists) administered concurrently with study

          -  No other uncontrolled concurrent illness (e.g., infection)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after study
             therapy

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Chemotherapy

          -  No concurrent colony stimulating factors during topotecan administration

        Chemotherapy:

          -  See Disease Characteristics

          -  No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell
             transplantation

          -  At least 4 weeks since prior chemotherapy and recovered

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy to whole pelvic field

          -  At least 2 weeks since prior radiotherapy and recovered

        Surgery:

          -  No unresolved sequelae resulting from prior surgery

        Other:

          -  At least 4 weeks since other prior investigational drug

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Howard S. Hochster, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00006391

Organization ID

CDR0000068275

Secondary IDs

U01CA070075

Study Sponsor

NYU Langone Health

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Howard S. Hochster, MD, Study Chair, NYU Langone Health

Verification Date

April 2011