Gefitinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Colorectal Cancer

NCT00025142 | Completed Phase 2

• 3 other identifiers: SUMC-670CDR0000068923NCI-4370
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with gefitinib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum

Interventions

FOLFOX regimen DRUG

fluorouracil DRUG

gefitinib DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Phase I (closed as of 5/30/02): * Histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective * Phase II: * Histologically confirmed metastatic or unresectable colorectal adenocarcinoma * Measurable disease or assessable but nonmeasurable disease (including ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT scan/MRI), or cystic lesions) * Disease characterized only by elevated serum tumor marker allowed * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * More than 3 months Hematopoietic: * 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 * AST/ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal 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 ongoing or active infection * No peripheral neuropathy * No prior allergic reactions to compounds of similar chemical or biologic composition to gefitinib or other study agents * No other concurrent uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow or stem cell support with high-dose chemotherapy * At least 24 hours since prior colony-stimulating growth factors Chemotherapy: * See Biologic therapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No more than 3 prior chemotherapy regimens Endocrine therapy: * At least 2 weeks since prior hormonal therapy except megestrol for anorexia/cachexia Radiotherapy: * No prior pelvic or whole abdominal radiotherapy * At least 4 weeks since other prior radiotherapy and recovered Surgery: * At least 4 weeks since prior major surgery (e.g., laparotomy) and recovered Other: * At least 4 weeks since prior investigational therapy * No other concurrent investigational or commercial anticancer agents * No concurrent combination antiretroviral therapy for HIV-positive patients

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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Cancer Center at Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (3)

• Fisher GA, Kuo T, Ramsey M, Schwartz E, Rouse RV, Cho CD, Halsey J, Sikic BI. A phase II study of gefitinib, 5-fluorouracil, leucovorin, and oxaliplatin in previously untreated patients with metastatic colorectal cancer. Clin Cancer Res. 2008 Nov 1;14(21):7074-9. doi: 10.1158/1078-0432.CCR-08-1014.

  PMID: 18981005 RESULT

• Kuo T, Cho CD, Halsey J, Wakelee HA, Advani RH, Ford JM, Fisher GA, Sikic BI. Phase II study of gefitinib, fluorouracil, leucovorin, and oxaliplatin therapy in previously treated patients with metastatic colorectal cancer. J Clin Oncol. 2005 Aug 20;23(24):5613-9. doi: 10.1200/JCO.2005.08.359.

  PMID: 16110021 RESULT

• Cho CD, Fisher GA, Halsey JZ, et al.: A phase I study of ZD1839 (Iressa) in combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) in advanced solid malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-38, 2002.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Gefitinib; Leucovorin; Oxaliplatin

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Branimir I. Sikic, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Study Completion: November 1, 2006
• Last Updated: May 15, 2013

Record last verified: 2005-02

Locations

US (1)