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CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
paclitaxel poliglumex
Sponsored by
Memorial Sloan Kettering Cancer Center
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, primary peritoneal cavity cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma Recurrent disease following prior initial therapy with platinum-based regimen No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease No more than 1 prior non-platinum, non-taxane regimen At least 1 site of radiographically measurable disease AND/OR CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples PATIENT CHARACTERISTICS: Age Not specified Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Alkaline phosphatase less than 1.5 times ULN Renal Creatinine no greater than 1.5 mg/dL Other No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior immunotherapy and recovered Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy At least 4 weeks since prior endocrine therapy and recovered Radiotherapy At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered Surgery Not specified Other At least 4 weeks since other prior investigational drugs and recovered

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
May 29, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017017
Brief Title
CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer
Official Title
A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
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. PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.
Detailed Description
OBJECTIVES: Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with CT-2103. Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients. OUTLINE: This is a dose-escalation study. Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the remaining patients receive a higher dose of CT-2103. Patients are followed between 1-3 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 20-40 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, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paclitaxel poliglumex

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma Recurrent disease following prior initial therapy with platinum-based regimen No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease No more than 1 prior non-platinum, non-taxane regimen At least 1 site of radiographically measurable disease AND/OR CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples PATIENT CHARACTERISTICS: Age Not specified Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Alkaline phosphatase less than 1.5 times ULN Renal Creatinine no greater than 1.5 mg/dL Other No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior immunotherapy and recovered Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy At least 4 weeks since prior endocrine therapy and recovered Radiotherapy At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered Surgery Not specified Other At least 4 weeks since other prior investigational drugs and recovered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sabbatini, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer

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