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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00262808
First received: December 6, 2005
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 chemotherapy or kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This phase II trial is studying how well GM-CSF and combination chemotherapy work in treating patients who are undergoing surgery for stage II or stage III colon cancer.


Condition Intervention Phase
Colorectal Cancer
Biological: sargramostim
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE II Study of GM-CSF As Pre- And Post-operative Adjuvant Therapy For Stage II And III Colon Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Proportion of patients with a change in tumor-associated macrophage VEGF expression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262808

Locations
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Alok A. Khorana, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00262808     History of Changes
Other Study ID Numbers: CDR0000448633, URCC-U1203, URCC-RSRB-09956, BRLX-001-0837, DUMC-7135-05-5R0
Study First Received: December 6, 2005
Last Updated: October 14, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
stage II colon cancer
stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Fluorouracil
Levoleucovorin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014