Oxaliplatin and Topotecan in Advance Ovarian Cancer

NCT ID: NCT00313612

Last Updated: 2015-11-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Recurrent Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

oxaliplatin

Intervention Type: DRUG

Given IV

topotecan

Intervention Type: DRUG

Given IV

Interventions

oxaliplatin

Given IV

Intervention Type: DRUG

topotecan

Given IV

Intervention Type: DRUG

Other Intervention Names

Dacotin; Dacplat; Eloxatin; L-OHP; hycamptamine; Hycamtin; SKF S-104864-A; TOPO; 1-OHP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Tiersten

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

NYU Cancer Institute

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24172094 (View on PubMed)

Other Identifiers

NYU 03-67

Identifier Type: OTHER

Identifier Source: secondary_id

N01CM62204

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00053

Identifier Type: -

Identifier Source: org_study_id