Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

GM-CSF and Combination Chemotherapy in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Colon Cancer

Lead Sponsor:

University of Rochester

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of ...

Detailed Description

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 effic...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2006

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00262808

    Start Date

    March 1 2004

    End Date

    September 1 2006

    Last Update

    October 16 2013

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, United States, 14642

    2

    Duke Comprehensive Cancer Center

    Durham, North Carolina, United States, 27710