Oxaliplatin and Topotecan in Advance Ovarian Cancer

Recurrent Ovarian Epithelial Cancer Clinical Trial

Official title:

A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00313612
• Other study ID #: NCI-2009-00053
• Secondary ID: NYU 03-67N01CM62
• Status: Terminated
• Phase: Phase 2
• First received: April 11, 2006
• Last updated: October 27, 2015
• Start date: January 2006
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: December 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms
• Recurrent Ovarian Epithelial Cancer

Intervention

Drug:
• oxaliplatin
Given IV
• topotecan
Given IV

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	NYU Cancer Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every two cycles for up to 24 weeks.	No
Secondary	Time to Disease Progression by RECIST and/or CA 125	Time to disease progression by RECIST and/or CA 125	Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks	No