search
Back to results

Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
capecitabine
gefitinib
oxaliplatin
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed* colorectal cancer Metastatic disease The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is not required for recurrent metastatic disease unless an interval of > 5 years has elapsed between the initial primary surgery and the development of metastases Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No CNS metastases PATIENT CHARACTERISTICS: Age 18 to 80 Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ ULN No unstable or uncompensated hepatic disease Renal Creatinine < 1.5 times ULN OR Creatinine clearance > 60 mL/min No unstable or uncompensated renal disease Cardiovascular No unstable or uncompensated cardiac disease Pulmonary No evidence of clinically active interstitial lung disease Asymptomatic patients with chronic stable radiographic changes are eligible No unstable or uncompensated respiratory disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No known hypersensitivity to gefitinib or any of its excipients No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine No severe or uncontrolled systemic disease Able to receive oral medication No known dihydropyrimidine dehydrogenase (DPD) deficiency No known peripheral neuropathy ≥ grade 1 Absence of deep tendon reflexes as the sole neurological abnormality allowed No other significant clinical disorder or laboratory finding that would preclude study participation No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I) No prior chemotherapy for metastatic disease (phase II) Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease No prior irinotecan and oxaliplatin (phase II) Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy for colorectal cancer Surgery See Disease Characteristics More than 4 weeks since prior major surgery (e.g., laparotomy) Other Recovered from all prior therapy (no unresolved chronic toxicity > grade 2) More than 4 weeks since prior investigational drugs No prior epidermal growth factor receptor inhibitor therapy (phase II) No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort) No other concurrent investigational drugs No other concurrent systemic therapy for colorectal cancer

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Maximum tolerated dose
Response rate

Secondary Outcome Measures

Toxicity
1-year survival (phase II)
Progression-free survival (phase II)
Overall survival in (phase II)

Full Information

First Posted
July 8, 2004
Last Updated
January 31, 2013
Sponsor
Roswell Park Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00087334
Brief Title
Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer
Official Title
A Phase I/II Study of Capecitabine (XELODA®, Roche) Plus Oxaliplatin (Eloxatin®, Sanofi) Plus ZD 1893 (IRESSA®) in the Treatment of Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to poor/low accrual
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining capecitabine and oxaliplatin with gefitinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with oxaliplatin and gefitinib and to see how well they work in treating patients with metastatic colorectal cancer.
Detailed Description
OBJECTIVES: Primary Determine the maximum tolerated dose of capecitabine when given in combination with oxaliplatin and gefitinib in patients with metastatic colorectal cancer. (phase I) Determine the response rate in patients treated with this regimen. (phase II) Secondary Determine the safety and toxic effects of this regimen in these patients. Determine the 1-year survival of patients treated with this regimen. (phase II) Determine the progression-free and overall survival of patients treated with this regimen. (phase II) OUTLINE: This is an open-label, nonrandomized, phase I, dose-escalation study of capecitabine followed by a phase II study. Phase I: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1. Patients also receive oral gefitinib once daily beginning 5 days before the initiation of capecitabine and oxaliplatin and continuing for the duration of study treatment. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of capecitabine 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. Phase II: Patients receive oral capecitabine (at the MTD determined in phase I), oxaliplatin IV, and oral gefitinib as in phase I. Patients are followed for survival. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 1-12 months; and a total of 26 patients will be accrued for the phase II portion of this study within 8-13 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
gefitinib
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Title
Response rate
Secondary Outcome Measure Information:
Title
Toxicity
Title
1-year survival (phase II)
Title
Progression-free survival (phase II)
Title
Overall survival in (phase II)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed* colorectal cancer Metastatic disease The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: *Confirmation is not required for recurrent metastatic disease unless an interval of > 5 years has elapsed between the initial primary surgery and the development of metastases Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No CNS metastases PATIENT CHARACTERISTICS: Age 18 to 80 Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ ULN No unstable or uncompensated hepatic disease Renal Creatinine < 1.5 times ULN OR Creatinine clearance > 60 mL/min No unstable or uncompensated renal disease Cardiovascular No unstable or uncompensated cardiac disease Pulmonary No evidence of clinically active interstitial lung disease Asymptomatic patients with chronic stable radiographic changes are eligible No unstable or uncompensated respiratory disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No known hypersensitivity to gefitinib or any of its excipients No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine No severe or uncontrolled systemic disease Able to receive oral medication No known dihydropyrimidine dehydrogenase (DPD) deficiency No known peripheral neuropathy ≥ grade 1 Absence of deep tendon reflexes as the sole neurological abnormality allowed No other significant clinical disorder or laboratory finding that would preclude study participation No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I) No prior chemotherapy for metastatic disease (phase II) Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease No prior irinotecan and oxaliplatin (phase II) Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy for colorectal cancer Surgery See Disease Characteristics More than 4 weeks since prior major surgery (e.g., laparotomy) Other Recovered from all prior therapy (no unresolved chronic toxicity > grade 2) More than 4 weeks since prior investigational drugs No prior epidermal growth factor receptor inhibitor therapy (phase II) No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort) No other concurrent investigational drugs No other concurrent systemic therapy for colorectal cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwan Fakih, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Capecitabine, Oxaliplatin, and Gefitinib in Treating Patients With Metastatic Colorectal Cancer

We'll reach out to this number within 24 hrs