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

A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Ovarian Carcinoma; Primary Peritoneal Carcinoma
• Intervention / Treatment: Drug: Paclitaxel Poliglumex

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Gynecologic Oncology Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Given IV; Other Names: CT-2103; Paclitaxel Polyglutamate; PG-TXL; Xyotax

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in objective response	Baseline to 5 years
Change in observed adverse effects	Baseline to 5 years

Collaborators and Investigators

• Sponsor: Gynecologic Oncology Group
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Paul Sabbatini, Gynecologic Oncology Group

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): July 15, 2006

Study Registration Dates

• First Submitted: September 6, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel; Paclitaxel poliglumex
• Other Study ID Numbers: GOG-0186C (Other Identifier: CTEP); U10CA027469 (U.S. NIH Grant/Contract); NCI-2012-02493 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CDR0000257039