Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy such as epothilone D work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well epothilone D works as second-line therapy in treating patients with advanced or metastatic refractory colorectal cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the antitumor activity of epothilone D as second-line treatment, in terms of objective response rate, in patients with advanced or metastatic refractory colorectal cancer.

Secondary

• Determine the safety of this drug in these patients.

• Determine the response duration in patients responding to treatment with this drug.

• Determine time to tumor progression and overall survival in patients treated with this drug.

• Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 19-69 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the colon or rectum

• Evidence of at least 1 site of unidimensionally measurable disease by radiography or physical examination

• Failed 1 prior treatment with a fluoropyrimidine in combination with either irinotecan OR oxaliplatin for advanced or metastatic disease

• No known CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Hemoglobin ≥ 9 g/dL

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN (5 times ULN if hepatic metastases are present)

• Alkaline phosphatase ≤ 5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV congestive heart failure

• No QTc > 450 msec for males or > 470 msec for females

• No personal or family history of congenital long QT syndrome

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No pre-existing neuropathy grade 2 or greater

• No documented grade 3 or 4 hypersensitivity reaction to prior therapy containing Cremophor

• No infection requiring parenteral or oral anti-infective treatment

• No altered mental status or psychiatric condition that would preclude giving informed consent

• No other medical condition that would preclude study participation

• No other malignancy within the past 5 years except cured basal cell skin cancer, carcinoma in situ of the cervix or bladder, or stage T1 or T2 prostate cancer with a prostate-specific antigen < 2 ng/mL

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent sargramostim (GM-CSF)

• No concurrent routine prophylactic use of filgrastim (G-CSF)

Chemotherapy

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• At least 3 weeks since prior radiotherapy and recovered

Surgery

• At least 3 weeks since prior surgery and recovered

Other

• More than 3 weeks since prior investigational agents (therapeutic or diagnostic)

• No other concurrent therapy for advanced or metastatic colorectal cancer

• No other concurrent investigational drugs

Trial Contact Information

Trial Lead Organizations/Sponsors

Memorial Sloan-Kettering Cancer Center

Leonard Bruce Saltz

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00077259
Information obtained from ClinicalTrials.gov on February 06, 2012

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