Colorectal CancerPhase 1/2NCT00026299
Oxaliplatin With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
A Phase 1/2 study testing ZD1839 and oxaliplatin in people with Colorectal Cancer, run by University of Chicago at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- ZD1839 and oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2001to Feb 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
Evanston Northwestern Health Care
Evanston, Illinois, 60201
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46885-5099
Ingalls Memorial Hospital
Harvey, Illinois, 60426
LaGrange Memorial Hospital
LaGrange, Illinois, 60525
Loyola University Medical Center
Maywood, Illinois, 60153-5589
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, 49085
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
About this study
Official title: A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma
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.
Read the detailed description
OBJECTIVES:
- Determine the recommended phase II dose of gefitinib when administered in combination with oxaliplatin in patients with metastatic or locally recurrent colorectal cancer.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Compare the time to progression, objective response rate, and median and overall survival in patients treated with oxaliplatin with or without gefitinib.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a phase I dose-escalation study of gefitinib followed by a phase II randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2).
- Phase I: Patients receive oxaliplatin IV over 2 hours on day 1 and oral gefitinib once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib 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 are randomized to one of two treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive oxaliplatin as in arm I and oral gefitinib once daily at the MTD on days 1-21.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive gefitinib alone until disease progression.
PROJECTED ACCRUAL: Approximately 77 patients (9 for phase I and 68 for phase II) will be accrued for this study within 12-14 months.
- Conditions
- Colorectal Cancer
- Being tested
- ZD1839, oxaliplatin
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD1839Drug
Also called gefitinib, Iressa ®
oxaliplatinDrug
Also called Eloxatin ®
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: ZD1839; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended dose of ZD1839 in combination with oxaliplatin
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2001
- Primary completionDec 2002
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hedy L. Kindler, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026299
- Sponsor's protocol ID
- 11089A
- Other IDs
- UCCRC-11089, NCI-3857
- Status last verified
- Sep 2013
- First submitted
- 9 Nov 2001
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16062074
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/ Randomized Phase II Trial Of Oxaliplatin (NSC #266046) With Or Without ZD 1839 (NSC # 715055) In Patients With Advanced Colorectal Carcinoma
- ClinicalTrials.gov ID
- NCT00026299
- Acronym / sponsor ID
- 11089A
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the recommended phase II dose of gefitinib when administered in combination with oxaliplatin in patients with metastatic or locally recurrent colorectal cancer.
- Determine the dose-limiting toxicity of this regimen in these patients.
- Compare the time to progression, objective response rate, and median and overall survival in patients treated with oxaliplatin with or without gefitinib.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a phase I dose-escalation study of gefitinib followed by a phase II randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1-2).
- Phase I: Patients receive oxaliplatin IV over 2 hours on day 1 and oral gefitinib once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gefitinib 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 are randomized to one of two treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive oxaliplatin as in arm I and oral gefitinib once daily at the MTD on days 1-21.
In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II with stable or responding disease after 6 courses may continue to receive gefitinib alone until disease progression.
PROJECTED ACCRUAL: Approximately 77 patients (9 for phase I and 68 for phase II) will be accrued for this study within 12-14 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 2: Oxaliplatin plus ZD1839 | Experimental | Drug: ZD1839, Drug: oxaliplatinOxaliplatin 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. |
| Phase 2: Oxaliplatin alone | Experimental | Drug: oxaliplatinOxaliplatin 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. |
| Phase I: Oxaliplatin with ZD1839 | Experimental | Drug: ZD1839, Drug: oxaliplatinOxaliplatin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD1839Also: gefitinib, Iressa ® | Drug | Phase 2: Oxaliplatin plus ZD1839, Phase I: Oxaliplatin with ZD1839 |
| oxaliplatinAlso: Eloxatin ® | Drug | Phase 2: Oxaliplatin alone, Phase 2: Oxaliplatin plus ZD1839, Phase I: Oxaliplatin with ZD1839 |
Primary outcome
Recommended dose of ZD1839 in combination with oxaliplatin
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
- Results publication: PubMed 16062074Kindler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hedy L. Kindler, MD study chair
University of Chicago
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZD1839 and oxaliplatin in people with Colorectal Cancer, run by University of Chicago at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended dose of ZD1839 in combination with oxaliplatin (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00026299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.