NCT00026364

Brief Summary

Phase I trial to study the effectiveness of ZD 1839 combined with irinotecan, leucovorin, and fluorouracil in treating patients who have locally advanced, locally recurrent, or metastatic colorectal cancer. Biological therapies such as ZD 1839 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 ZD 1839 with combination chemotherapy may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

June 25, 2003

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Last Updated

March 21, 2013

Status Verified

September 1, 2002

Enrollment Period

5.1 years

First QC Date

November 9, 2001

Last Update Submit

March 19, 2013

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral ZD 1839 daily. Beginning on day 15, patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15 minutes, and fluorouracil IV weekly on weeks 1-2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ZD 1839 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are accrued to receive treatment at the MTD.

Drug: fluorouracilDrug: gefitinibDrug: irinotecan hydrochlorideDrug: leucovorin calcium

Interventions

fluorouracilDRUG
Arm I
gefitinibDRUG
Arm I
irinotecan hydrochlorideDRUG
Arm I
leucovorin calciumDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum * Locally advanced, locally recurrent, or metastatic disease * Not curable by surgery and/or not amenable to radiotherapy with curative intent * Histological or cytological confirmation of metastatic cancer not required for patients with prior surgically resected colorectal cancer if more than 5 years elapsed between primary surgery and development of metastatic disease OR if primary cancer was stage I or II * Prior adjuvant therapy with fluorouracil or immunotherapy for resected stage II, III, or IV disease allowed * Measurable disease * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 12 weeks 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 normal * AST/ALT no greater than 5 times upper limit of normal Renal: * Creatinine normal Cardiovascular: * No uncontrolled high blood pressure * No unstable angina * No symptomatic congestive heart failure * No myocardial infarction within the past 6 months * No serious uncontrolled cardiac arrhythmia * No New York Heart Association class III or IV heart disease Other: * No active or uncontrolled infection * No predisposing colonic or small bowel disorders with uncontrolled symptoms as indicated by more than 3 loose stools daily in patients without a colostomy or ileostomy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas * No other concurrent medical or psychiatric condition that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 12 months since prior immunotherapy Chemotherapy: * At least 12 months since prior fluorouracil * No prior chemotherapy for advanced colorectal cancer * No prior irinotecan Radiotherapy: * No prior radiotherapy to more than 15% of bone marrow * At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy) * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery (e.g., laparotomy) and recovered * At least 2 weeks since prior minor surgery and recovered * No concurrent ophthalmic surgery Other: * No prior ZD 1839 * No other concurrent investigational or commercial agents or therapies for malignancy * No concurrent combination antiretroviral therapy for HIV * No concurrent oral retinoids * No concurrent prochlorperazine on day of irinotecan administration

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

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Meyerhardt JA, Clark JW, Supko JG, Eder JP, Ogino S, Stewart CF, D'Amato F, Dancey J, Enzinger PC, Zhu AX, Ryan DP, Earle CC, Mayer RJ, Michelini A, Kinsella K, Fuchs CS. Phase I study of gefitinib, irinotecan, 5-fluorouracil and leucovorin in patients with metastatic colorectal cancer. Cancer Chemother Pharmacol. 2007 Oct;60(5):661-70. doi: 10.1007/s00280-006-0411-6. Epub 2007 Jan 11.

    PMID: 17216531RESULT

  • Wolpin BM, Clark JW, Meyerhardt JA, Earle CC, Ryan DP, Enzinger PC, Zhu AX, Blaszkowsky L, Battu S, Fuchs CS. Phase I study of gefitinib plus FOLFIRI in previously untreated patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2006 Sep;6(3):208-13. doi: 10.3816/CCC.2006.n.037.

    PMID: 17026790RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

FluorouracilGefitinibIrinotecanLeucovorin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesCoenzymesEnzymes and Coenzymes

Study Officials

  • Charles S. Fuchs, MD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2001

First Posted

June 25, 2003

Study Start

November 1, 2001

Primary Completion

December 1, 2006

Last Updated

March 21, 2013

Record last verified: 2002-09

Locations

US(2)