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Oxaliplatin and Topotecan in Advance Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00313612
Recruitment Status : Terminated
First Posted : April 12, 2006
Results First Posted : November 27, 2015
Last Update Posted : November 27, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
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. 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.

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Epithelial Cancer Drug: oxaliplatin Drug: topotecan Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

II. Determine the toxic effects in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer
Study Start Date : January 2006
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: Treatment (oxaliplatin plus topotecan)
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.
Drug: oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Dacotin
  • Dacplat
  • Eloxatin
  • L-OHP

Drug: topotecan
Given IV
Other Names:
  • hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • TOPO




Primary Outcome Measures :
  1. Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) [ Time Frame: Every two cycles for up to 24 weeks. ]
    Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.


Secondary Outcome Measures :
  1. Time to Disease Progression by RECIST and/or CA 125 [ Time Frame: Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks ]
    Time to disease progression by RECIST and/or CA 125



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

Inclusion Criteria:

  • Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
  • 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
  • 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
  • Life expectancy >= 4 months
  • 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

Exclusion criteria:

  • 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., 5HT3 antagonists)
  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00313612


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
NYU Cancer Institute
New York, New York, United States, 10016
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amy Tiersten Montefiore Medical Center

Publications of Results:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00313612     History of Changes
Other Study ID Numbers: NCI-2009-00053
NYU 03-67 ( Other Identifier: New York University )
N01CM62204 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2006    Key Record Dates
Results First Posted: November 27, 2015
Last Update Posted: November 27, 2015
Last Verified: May 2013

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Oxaliplatin
Topotecan
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action