Clinical trial NCT00017017: CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer
Official title: A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-11-13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Paul Sabbatini, MD
role: STUDY_CHAIR
References: