CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT00045682)

Study summary

Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Read the detailed description

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of polyglutamate paclitaxel (CT-2103) as third-line treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions studied

Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma

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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 78 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

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Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer after second-line therapy
- Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior second-line (non-platinum, non-taxane) chemotherapy regimen
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- At least 1 target lesion that has not previously been irradiated
Ineligible for a higher priority GOG protocol (if one exists)
Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant disease
Performance status - GOG 0-2
Absolute neutrophil count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3
No active bleeding
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN
PT or PTT less than ULN
Creatinine no greater than 1.5 times ULN
No uncontrolled hypertension
No uncompensated congestive heart failure
No symptomatic coronary artery disease
No myocardial infarction within the past 6 months
No sensory or motor neuropathy greater than grade 1
No active infection requiring antibiotics
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
At least 3 weeks since prior biological therapy or immunotherapy directed at the malignancy
No prior polyglutamate paclitaxel (CT-2103)
Recovered from prior chemotherapy
At least 1 week since prior hormonal therapy directed at the malignancy
Concurrent hormone replacement therapy allowed
Recovered from prior radiotherapy
No prior radiotherapy to more than 25% of bone marrow
Recovered from prior surgery
At least 3 weeks since other prior therapy directed at the malignancy
No prior therapy for another malignancy that would preclude this study
No concurrent amifostine or other protective reagents

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 78 participants (actual)

Study arms

Experimental
Treatment (polyglutamate paclitaxel)
Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel Poliglumex

Interventions

DrugPaclitaxel Poliglumex
Given IV
Also known as: CT-2103, Paclitaxel Polyglutamate, PG-TXL, Xyotax

What researchers measure

Primary outcomes

Frequency and duration of objective response
Time frame: 5 years
Frequency and severity of observed adverse effects
Time frame: 5 years
Survival time
Time frame: 5 years
Duration of progression-free interval
Time frame: 5 years

Secondary outcomes

Change in objective response
Time frame: Baseline to 5 years
Change in observed adverse effects
Time frame: Baseline to 5 years

Study locations

1 site

Gynecologic Oncology Group
Philadelphia, Pennsylvania 19103, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00045682
Lead sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jan 27, 2003
Start date: Sep 2002
Primary completion: Jul 15, 2006
Last update: Jul 13, 2017

Study contacts

Paul Sabbatini

principal investigator · Gynecologic Oncology Group

View the source record on ClinicalTrials.gov ↗

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