BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer

The University of Chicago

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: BMS-247550

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00022477

11003B

NCI-3670

UCCRC-11003B

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 II trial to study the effectiveness of BMS-247550 in treating patients who have recurrent or metastatic colorectal cancer.

Full description

OBJECTIVES:

Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with BMS-247550.
Determine the toxicity of this drug in these patients.
Determine the duration of response, median and overall survival, and time to progression in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 8-10 months.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- The following are not considered measurable lesions:
  - Lesions seen on colonoscopic examination or barium study
  - Bone metastases
  - CNS lesions
  - Ascites
Failed prior combination therapy comprising fluorouracil, leucovorin calcium, and irinotecan for metastatic disease
No brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

At least 3 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
ALT/AST no greater than 2.5 times upper limit of normal

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No grade 2 or greater peripheral neuropathy
No history of allergic hypersensitivity reaction to compounds containing polyoxyethylated castor oil (Cremophor EL) (e.g., paclitaxel or compounds of similar chemical or biological composition to BMS-247550)
No other currently active malignancy (less than 30% risk of relapse and completed prior therapy) except non-melanoma skin cancer or carcinoma in situ of the cervix
No uncontrolled illness
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunotherapy
No concurrent colony-stimulating factors during first course of therapy

Chemotherapy:

See Disease Characteristics
Prior adjuvant chemotherapy allowed
At least 4 weeks since prior cytotoxic chemotherapy and recovered
No more than 1 prior chemotherapy regimen for metastatic disease
No other concurrent chemotherapy

Endocrine therapy:

No concurrent anticancer hormonal therapy

Radiotherapy:

At least 4 weeks since prior radiotherapy and recovered
No concurrent therapeutic radiotherapy

Surgery:

See Disease Characteristics
At least 4 weeks since prior surgery

Other:

At least 30 days since prior investigational agents
At least 7 days since prior cimetidine
No other concurrent anticancer investigational agents, commercial agents, or therapies
No concurrent unconventional therapy, food, or vitamin supplement containing Hypericum perforatum (St. John's Wort)
No concurrent cimetidine
No concurrent combination antiretroviral therapy for HIV-positive patients