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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017017
First received: June 6, 2001
Last updated: May 29, 2013
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: paclitaxel poliglumex
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Study Completion Date: December 2009
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017017

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Paul Sabbatini, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00017017     History of Changes
Other Study ID Numbers: CTI-1071, MSKCC-01024, CDR0000068642, NCI-G01-1947
Study First Received: June 6, 2001
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014