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Oxaliplatin and Topotecan in Advance Ovarian Cancer

Primary Purpose

Recurrent Ovarian Epithelial Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
topotecan
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center
  • NYU Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (oxaliplatin plus topotecan)

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
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

Time to Disease Progression by RECIST and/or CA 125
Time to disease progression by RECIST and/or CA 125

Full Information

First Posted
April 11, 2006
Last Updated
October 27, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00313612
Brief Title
Oxaliplatin and Topotecan in Advance Ovarian Cancer
Official Title
A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Ovarian Epithelial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (oxaliplatin plus topotecan)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Other Intervention Name(s)
1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
topotecan
Other Intervention Name(s)
hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Description
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.
Time Frame
Every two cycles for up to 24 weeks.
Secondary Outcome Measure Information:
Title
Time to Disease Progression by RECIST and/or CA 125
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Tiersten
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467-2490
Country
United States
Facility Name
NYU Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24172094
Citation
Stein SM, Tiersten A, Hochster HS, Blank SV, Pothuri B, Curtin J, Shapira I, Levinson B, Ivy P, Joseph B, Guddati AK, Muggia F. A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer. Int J Gynecol Cancer. 2013 Nov;23(9):1577-82. doi: 10.1097/IGC.0b013e3182a809e0.
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Oxaliplatin and Topotecan in Advance Ovarian Cancer

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