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

NCT00262808 | Completed Phase 2

• 5 other identifiers: CDR0000448633URCC-U1203URCC-RSRB-09956BRLX-001-0837DUMC-7135-05-5R0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; stage III colon cancer; adenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Disease-free and overall survival

Interventions

sargramostim BIOLOGICAL

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

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

Rochester, New York, 14642, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Bourigault P, Skwarski M, Macpherson RE, Higgins GS, McGowan DR. Investigation of atovaquone-induced spatial changes in tumour hypoxia assessed by hypoxia PET/CT in non-small cell lung cancer patients. EJNMMI Res. 2021 Dec 29;11(1):130. doi: 10.1186/s13550-021-00871-x.

  PMID: 34964932 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

sargramostim; Fluorouracil; Leucovorin; Oxaliplatin; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Alok A. Khorana, MD

  James P. Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: March 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (2)