Ovarian Cancer Clinical Trial

Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.

View Full Description

Full Description

OBJECTIVES:

Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
Determine the qualitative and quantitative toxic effects of this regimen in these patients.
Determine the pharmacokinetics of this regimen in these patients.
Determine the antitumor activity of this treatment regimen in these patients.
Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed through day 30.

PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer

Prior chemotherapy required
Measurable or evaluable disease
No symptomatic, untreated brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 70-100%

Life expectancy:

At least 4 months

Hematopoietic:

WBC greater than 3,000/mm^3
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases)

Renal:

Creatinine no greater than 1.5 times ULN OR
Creatinine clearance at least 50 mL/min

Cardiovascular:

No uncontrolled symptomatic congestive heart failure
No unstable angina pectoris
No uncontrolled cardiac arrhythmia

Other:

No other active cancer
No prior allergy to platinum compounds
No prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study
No other uncontrolled concurrent illness (e.g., infection)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Chemotherapy
No concurrent colony stimulating factors during topotecan administration

Chemotherapy:

See Disease Characteristics
No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell transplantation
At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to whole pelvic field
At least 2 weeks since prior radiotherapy and recovered

Surgery:

No unresolved sequelae resulting from prior surgery

Other:

At least 4 weeks since other prior investigational drug
No other concurrent investigational agents
No other concurrent anticancer therapy

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Study ID:

NCT00006391

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Study ID:

NCT00006391

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider