CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: paclitaxel poliglumex

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00017017

CTI-1071

CDR0000068642 (Registry Identifier)

NCI-G01-1947

MSKCC-01024

Details and patient eligibility

About

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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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