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


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

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Trial Information

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


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.


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

- No symptomatic, untreated brain metastases

- Karnofsky performance status 70-100%

- WBC > 3,000/mm3

- Absolute neutrophil count > 1,500/mm3

- Platelet count > 100,000/mm3

- 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., 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

- 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

- 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

- HIV negative

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical response rate (complete and partial response by RECIST and/or CA [cancer antigen] 125)

Outcome Time Frame:

56 days

Safety Issue:

No

Principal Investigator

Amy Tiersten

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00053

NCT ID:

NCT00313612

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Montefiore Medical CenterBronx, New York  10467-2490
NYU Cancer InstituteNew York, New York  10016