search
Back to results

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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oxaliplatin
topotecan hydrochloride
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 4, 2000
Last Updated
April 4, 2011
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006391
Brief Title
Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard S. Hochster, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Study Chair
Facility Information:
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18191187
Citation
Hochster H, Chen TT, Lu JM, Hills D, Sorich J, Escalon J, Ivy P, Liebes L, Muggia F. Tolerance and activity of oxaliplatin with protracted topotecan infusion in patients with previously treated ovarian cancer. A phase I study. Gynecol Oncol. 2008 Mar;108(3):500-4. doi: 10.1016/j.ygyno.2007.11.017. Epub 2008 Jan 11.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs