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A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CTI-1071

NCT ID:

NCT00017017

Start Date:

February 2001

Completion Date:

December 2009

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021