Clinical trial NCT00045682: CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Official title: A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Frequency and duration of objective response
timeFrame: 5 years
measure: Frequency and severity of observed adverse effects
timeFrame: 5 years
measure: Survival time
timeFrame: 5 years
measure: Duration of progression-free interval
timeFrame: 5 years
Secondary outcomes:
measure: Change in objective response
timeFrame: Baseline to 5 years
measure: Change in observed adverse effects
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Paul Sabbatini
role: PRINCIPAL_INVESTIGATOR
References: