Ovarian Cancer Clinical Trial
CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer
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.
Full Description
OBJECTIVES:
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age
Not specified
Performance status
Karnofsky 70-100%
Life expectancy
Not specified
Hematopoietic
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic
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
Renal
Creatinine no greater than 1.5 mg/dL
Other
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
At least 4 weeks since prior immunotherapy and recovered
Chemotherapy
See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy
At least 4 weeks since prior endocrine therapy and recovered
Radiotherapy
At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
Surgery
Not specified
Other
At least 4 weeks since other prior investigational drugs and recovered
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There is 1 Location for this study
New York New York, 10021, United States
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