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Oxaliplatin and Topotecan in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2007
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00313612
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: oxaliplatin
Drug: topotecan hydrochloride
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Topotecan hydrochloride Topotecan Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response rate (complete and partial response by RECIST and/or CA [cancer angigen] 125) at course 2 of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression by RECIST and/or CA 125 [ Designated as safety issue: No ]
  • Duration of overall clinical response [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: January 2006
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan.
  • Determine the toxic effects in patients treated with this regimen.

Secondary

  • Estimate the time to progression and overall clinical response duration in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to response to prior platinum therapy (resistant vs sensitive).

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • Measurable or evaluable disease

    • Measurable disease is characterized as lesions reproducibly measurable in 1 dimension
    • Evaluable disease is defined as known disease with CA125 levels > 50 U/mL on 2 occasions ≥ 1 week apart
  • Previously treated with a taxane and platinum-based regimen

    • Only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation
    • One additional non-platinum and non-topotecan chemotherapy regimen allowed
    • Any number of prior biologic therapies allowed
  • Meets 1 of the following criteria for response to prior platinum-based therapy:

    • Platinum-resistant disease, defined as a disease-free interval of < 6 months after prior platinum-based therapy OR progressive disease on a platinum-containing regimen
    • Platinum-sensitive disease, defined as a disease-free interval of > 6 months after prior platinum-based therapy
  • No symptomatic, untreated brain metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 4 months
  • WBC > 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.5 times ULN AND creatinine clearance > 40 mg/dL
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No presence of any other active cancer
  • No uncontrolled intercurrent illness, including the following:

    • Infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
  • No history of severe allergy to platinum compounds

    • Mild reaction (skin only) allowed provided a negative skin test is obtained
  • No history of allergic reaction to appropriate antiemetics (e.g., 5HT_3 antagonists)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior chemotherapy
  • At least 2 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior investigational drugs
  • No prior radiotherapy to the whole pelvic field
  • No unresolved sequelae resulting from any surgical procedures
  • No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during topotecan infusion
  • No concurrent participation in another investigational trial
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313612

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center     617-667-9925        
United States, New York
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center     212-746-1848        
St. Luke's - Roosevelt Hospital Center - St.Luke's Division Recruiting
New York, New York, United States, 10025
Contact: Contact Person     212-523-4000        
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Amy D. Tiersten, MD Weill Medical College of Cornell University
Investigator: Howard S. Hochster, MD New York University School of Medicine
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000467190, NYU-0367, NCI-6317
Study First Received: April 11, 2006
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00313612  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Oxaliplatin
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Topotecan
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009