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A PHASE II Study of GM-CSF As Pre- And Post-Operative Adjuvant Therapy For Stage II And III Colon Cancer


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

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Trial Information

A PHASE II Study of GM-CSF As Pre- And Post-Operative Adjuvant Therapy For Stage II And III Colon Cancer


OBJECTIVES:

Primary

- Determine the safety of neoadjuvant and adjuvant sargramostim (GM-CSF) and adjuvant
chemotherapy in patients with resectable stage II or III colon cancer.

- Determine the efficacy, in terms of enhanced tumor-associated macrophage response, of
this regimen in these patients.

Secondary

- Determine overall survival and time to progression in patients treated with this
regimen.

OUTLINE:

- Neoadjuvant therapy and surgery: Patients receive sargramostim (GM-CSF) subcutaneously
(SC) once daily beginning between days -16 and -12 and continuing until day -1.
Patients undergo surgical resection on day 0. Patients with stage I or IV disease are
removed from the study. All other patients proceed to adjuvant chemotherapy or
observation.

- Adjuvant chemotherapy or observation: Patients with high-risk stage II or any stage III
disease are assigned to group 1 or 2. Patients with low-risk stage II disease are
assigned to group 3.

- Group 1 (adjuvant therapy for high-risk stage II disease): Patients receive
leucovorin calcium IV over 2 hours and fluorouracil IV on days 1, 8, 15, 22, 29
and 36. Patients also receive GM-CSF SC once daily on days 50-54. Treatment
repeats every 56 days for up to 4 courses in the absence of disease progression or
unacceptable toxicity.

- Group 2 (adjuvant therapy for stage III disease): Patients receive adjuvant
chemotherapy and GM-CSF as in group 1. Alternatively, patients may receive
oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and
fluorouracil IV over 46 hours beginning on day 1. These patients also receive
GM-CSF SC once daily on days 10-14 of every fourth course. Treatment repeats every
14 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity.

- Group 3 (low-risk stage II disease): Patients undergo observation only every 3
months.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon

- Stage II or III disease

- No carcinoma in situ

- No perforated or obstructed tumors

- No dual primary lesions by colonoscopy or barium enema

- Resectable disease

- Distal and proximal bowel end must be > 5 cm from tumor

- Tumor must not extend below peritoneal reflection

- No distant intra-abdominal metastases (even if resected)

- No rectal cancer

- No tumors that require opening of the pelvic peritoneum to define the extent of
disease

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 2.0 mg/dL

Renal

- Creatinine ≤ 2.0 mg/dL

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No uncontrolled cardiac arrhythmia

Immunologic

- No ongoing or active infection

- No allergy to yeast or yeast-based products

- No allergy to sargramostim (GM-CSF)

- No allergy to fluorouracil

- No allergy to leucovorin calcium

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of Crohn's disease

- No history of ulcerative colitis

- No other malignancy within the past 3 years except superficial squamous cell or basal
cell skin cancer or carcinoma in situ of the cervix

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Chemotherapy

- No prior chemotherapy, including fluorouracil, for colon cancer

- No other concurrent chemotherapy

Radiotherapy

- No prior radiotherapy for colon cancer

- No concurrent radiotherapy

Other

- No other prior therapy for colon cancer

- No concurrent immunosuppressant therapy

- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with a change in tumor-associated macrophage VEGF expression

Safety Issue:

No

Principal Investigator

Alok A. Khorana, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000448633

NCT ID:

NCT00262808

Start Date:

March 2004

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642