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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017017
Recruitment Status : Completed
First Posted : November 13, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

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

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : February 2001
Actual Primary Completion Date : February 2003
Actual Study Completion Date : December 2009

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 1.5 mg/dL


  • 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


Biologic therapy

  • At least 4 weeks since prior immunotherapy and recovered


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

  • At least 4 weeks since prior endocrine therapy and recovered


  • At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered


  • Not specified


  • At least 4 weeks since other prior investigational drugs and recovered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00017017

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Paul Sabbatini, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00017017     History of Changes
Other Study ID Numbers: CTI-1071
CDR0000068642 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 13, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: December 2009

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

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases