Clinical trial NCT00313612: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Ovarian Epithelial Cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-04-12
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
timeFrame: Every two cycles for up to 24 weeks.
Secondary outcomes:
measure: Time to Disease Progression by RECIST and/or CA 125
timeFrame: Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Cancer Institute
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Amy Tiersten
role: PRINCIPAL_INVESTIGATOR
References:
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.