Ovarian Cancer Clinical Trial
CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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.
Full 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Philadelphia Pennsylvania, 19103, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.