Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

NCT00026299 | Completed Phase 1

• 3 other identifiers: 11089AUCCRC-11089NCI-3857
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 12

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of colorectal cancer. Combining chemotherapy with gefitinib may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of chemotherapy with or without gefitinib in treating patients who have metastatic or locally recurrent 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

Outcome Measures

Primary Outcomes (1)

• Recommended dose of ZD1839 in combination with oxaliplatin

  3 weeks

Study Arms (3)

Phase 2: Oxaliplatin plus ZD1839

EXPERIMENTAL

Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 and ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily (as determined during phase 1). Subjects can continue to receive the combination for 6 cycles (each cycle is 21 days). After 6 cycles of the combination, subjects can continue to take ZD1839 alone until their cancer worsens.

Drug: ZD1839; Drug: oxaliplatin

Phase 2: Oxaliplatin alone

EXPERIMENTAL

Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2 for up to 6 cycles. Each cycle will last 21 days.

Drug: oxaliplatin

Phase I: Oxaliplatin with ZD1839

EXPERIMENTAL

Oxaliplatin will be administered by IV infusion once every 21 days at a fixed dose of 130 mg/m2. ZD1839 will be taken orally at a dose of 250 mg or 500 mg daily.

Drug: ZD1839; Drug: oxaliplatin

Interventions

ZD1839 DRUG

Also known as: gefitinib, Iressa ®

Phase 2: Oxaliplatin plus ZD1839; Phase I: Oxaliplatin with ZD1839

oxaliplatin DRUG

Also known as: Eloxatin ®

Phase 2: Oxaliplatin alone; Phase 2: Oxaliplatin plus ZD1839; Phase I: Oxaliplatin with ZD1839

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is not amenable to potentially curative surgical resection * Metastatic or locally recurrent disease * Tumor in liver or lung accessible to needle biopsy by ultrasound or CT scan guidance * At least 1 measurable lesion * At least 20 mm by conventional techniques, including physical examination, CT scan, or MRI OR * At least 10 mm by spiral CT scan * Lesions on colonoscopic examination or barium studies, bone metastases, CNS lesions, and ascites are not considered measurable * Failed prior therapy with fluorouracil, leucovorin calcium, and irinotecan given either sequentially or in combination * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * 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 no greater than 1.5 mg/dL 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 peripheral neuropathy greater than grade 1 * No other concurrent uncontrolled illness that would preclude study * No concurrent psychiatric illness or social situation that would preclude study * No ongoing or active infection * No prior allergic reaction to compounds of similar chemical or biologic composition to oxaliplatin or gefitinib * No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless considered to be at less than 30% risk of relapse after completion of therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior epidermal growth factor inhibitor * At least 24 hours since prior colony-stimulating factors * No concurrent colony-stimulating factors during first course of study therapy Chemotherapy: * See Disease Characteristics * No more than 2 prior chemotherapy regimens for metastatic disease * Prior adjuvant chemotherapy allowed * At least 4 weeks since prior cytotoxic chemotherapy and recovered * No prior cisplatin or oxaliplatin Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery Other: * At least 30 days since prior investigational agents * Recovered from prior therapy * No concurrent anti-retroviral therapy for HIV * No other concurrent investigational or commercial agents or therapies for malignancy

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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

LaGrange Memorial Hospital

LaGrange, Illinois, 60525, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153-5589, United States

Location

Oncology/Hematology Associates of Central Illinois, P.C.

Peoria, Illinois, 61602, United States

Location

Central Illinois Hematology Oncology Center

Springfield, Illinois, 62701, United States

Location

Fort Wayne Medical Oncology and Hematology, Inc.

Fort Wayne, Indiana, 46885-5099, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Oncology Care Associates, P.L.L.C.

Saint Joseph, Michigan, 49085, United States

Location

Related Publications (1)

• Kindler HL, Friberg G, Skoog L, Wade-Oliver K, Vokes EE. Phase I/II trial of gefitinib and oxaliplatin in patients with advanced colorectal cancer. Am J Clin Oncol. 2005 Aug;28(4):340-4. doi: 10.1097/01.coc.0000159558.19631.d5.

  PMID: 16062074 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Gefitinib; 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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Hedy L. Kindler, MD

  University of Chicago

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: February 1, 2005
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (12)