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A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

A Phase II Study Of KOS-862 (Epothilone D), Administered Intravenously Weekly For 3 Weeks Every 4 Weeks, In The Second-Line Treatment Of Patients With Advanced Or Metastatic Colorectal Carcinoma (CRC)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

03-113

NCT ID:

NCT00077259

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • stage III colon cancer
  • stage III rectal cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021