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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006391
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 5, 2011
National Cancer Institute (NCI)
Information provided by:
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: oxaliplatin Drug: topotecan hydrochloride Phase 1

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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
Study Start Date : August 2000
Actual Primary Completion Date : November 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 4 months


  • WBC greater than 3,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3


  • 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)


  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 50 mL/min


  • No uncontrolled symptomatic congestive heart failure
  • No unstable angina pectoris
  • No uncontrolled cardiac arrhythmia


  • 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


Biologic therapy:

  • See Chemotherapy
  • No concurrent colony stimulating factors during topotecan administration


  • 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


  • No prior radiotherapy to whole pelvic field
  • At least 2 weeks since prior radiotherapy and recovered


  • No unresolved sequelae resulting from prior surgery


  • At least 4 weeks since other prior investigational drug
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006391

United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine

Publications of Results: Identifier: NCT00006391     History of Changes
Other Study ID Numbers: CDR0000068275
U01CA070075 ( U.S. NIH Grant/Contract )
P30CA016087 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: April 2011

Keywords provided by New York University School of Medicine:
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action