Adenocarcinoma of the RectumPhase 1/2NCT00006094

Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum

A Phase 1/2 study testing oxaliplatin, fluorouracil and external beam radiation therapy in people with Adenocarcinoma of the Rectum and Stage II Rectal Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer
What is being tested?: oxaliplatin, fluorouracil and external beam radiation therapy
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jul 2000to Oct 2006
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

Who may be able to join

Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
Locally advanced disease defined as any of the following:
Fixed or immovable tumor on physical exam
T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI
T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI
No distant metastatic disease

Show all 24Show fewer

Performance status - ECOG 0-2
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than upper limit of normal (ULN)
SGOT/SGPT no greater than 2.5 times ULN
Creatinine no greater than 1.5 mg/dL
Creatinine clearance at least 60 mL/min
No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix
Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse
No prior or concurrent evidence of neuropathy
No history of allergy to platinum compounds or antiemetics
Not pregnant or nursing
Fertile patients must use effective contraception
No prior fluorouracil or platinum-based therapy for any malignancy
No other concurrent chemotherapy
Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone)
No prior pelvic irradiation
No concurrent antiretroviral therapy (HAART) for HIV positive patients

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cancer and Leukemia Group B
Chicago, Illinois, 60606

Other trials in United States

About this study

Official title: A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum

Read the detailed description

PRIMARY OBJECTIVES:

Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum. (Phase I closed to accrual effective 03/27/2003). II. Determine the pathological response rate in patients treated with this preoperative regimen and surgical resection.

III.Determine the late toxicity of this preoperative regimen in these patients. IV. Determine, in a preliminary manner, the progression-free survival, local control, and overall survival in patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study of oxaliplatin.

Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level in the phase II portion of the study. (Phase I closed to accrual effective 03/27/2003). Patients may undergo radical resection of rectal tumor within 4-6 weeks after completion of chemoradiotherapy.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for phase I of the study (phase I closed to accrual effective 03/27/2003) and a total of 19 patients will be accrued for phase II of the study within 12-18 months.

Conditions: Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer
Being tested: oxaliplatin, fluorouracil, external beam radiation therapy
Medical subject headings: Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
fluorouracilDrug
Also called 5-fluorouracil, 5-Fluracil, 5-FU
Given IV
external beam radiation therapyRadiation
Also called EBRT
Undergo external beam radiation therapy

Study groups in NCT00006094
Study group	Role	What they receive
Treatment (oxaliplatin, fluorouracil, EBRT)	Experimental	Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: oxaliplatin; Drug: fluorouracil; Radiation: external beam radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas
Measured: 7 days
Progression-free survival
Will be estimated using the Kaplan-Meier method.
Measured: From protocol entry until documented progression of disease or death from any cause, assessed up to 5 years
Pathological complete response rate
The new regimen will be considered worthy of further investigation if 5 or greater CR's are observed among the 25 patients treated at the MTD. Assuming the new regimen will result in a 30% CR rate, the probability of observing 5 or greater CR's in 25 patients studied is 0.91. For an underlying CR rate of 0.25 this probability is 0.79. The probability of observing 5 or greater CR's if the underlying CR rate is 0.10 is 0.10.
Measured: Up to 5 years
Latent toxicities graded using the Common Toxicity Criteria (CTC) version 2.0
Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2000Oct 2006

First posted27 Jan 2003 (estimated)
Study startJul 2000
Primary completionOct 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Adenocarcinoma of the RectumStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00006094
Sponsor's protocol ID: NCI-2012-02357
Other IDs: CALGB-89901, U10CA031946, CDR0000068099
Status last verified: Jan 2013
First submitted: 3 Aug 2000
Last updated: 16 Jan 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma

All Adenocarcinoma of the Rectum trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Preoperative Oxaliplatin (NSC# 266046), 5-Fluorouracil, and External Beam Radiation Therapy in Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT00006094
Acronym / sponsor ID: NCI-2012-02357
Conditions: Adenocarcinoma of the Rectum, Stage II Rectal Cancer, Stage III Rectal Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: Jul 2000
Primary completion: Oct 2006 (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.

Detailed description

PRIMARY OBJECTIVES:

Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum. (Phase I closed to accrual effective 03/27/2003). II. Determine the pathological response rate in patients treated with this preoperative regimen and surgical resection.

OUTLINE: This is a dose-escalation, multicenter study of oxaliplatin.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (oxaliplatin, fluorouracil, EBRT)	Experimental	Drug: oxaliplatin, Drug: fluorouracil, Radiation: external beam radiation therapyPatients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Histologically proven previously untreated adenocarcinoma of the rectum thatbegins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy
No distant metastatic disease
Performance status - ECOG 0-2
Granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Key exclusion criteria (0 listed)

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
oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV	Drug	Treatment (oxaliplatin, fluorouracil, EBRT)
fluorouracilAlso: 5-fluorouracil, 5-Fluracil, 5-FUGiven IV	Drug	Treatment (oxaliplatin, fluorouracil, EBRT)
external beam radiation therapyAlso: EBRTUndergo external beam radiation therapy	Radiation	Treatment (oxaliplatin, fluorouracil, EBRT)

Primary outcome

The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas
Time frame: 7 days
Progression-free survival
Time frame: From protocol entry until documented progression of disease or death from any cause, assessed up to 5 years
Will be estimated using the Kaplan-Meier method.
Pathological complete response rate
Time frame: Up to 5 years
The new regimen will be considered worthy of further investigation if 5 or greater CR's are observed among the 25 patients treated at the MTD. Assuming the new regimen will result in a 30% CR rate, the probability of observing 5 or greater CR's in 25 patients studied is 0.91. For an underlying CR rate of 0.25 this probability is 0.79. The probability of observing 5 or greater CR's if the underlying CR rate is 0.10 is 0.10.
Latent toxicities graded using the Common Toxicity Criteria (CTC) version 2.0
Time frame: Up to 5 years

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 16 Jan 2013.

Related trials for Adenocarcinoma of the Rectum

RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Colon Adenocarcinoma, Rectal Adenocarcinoma

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.

David Ryan principal investigator

Cancer and Leukemia Group B

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 0 exclusion criteria. 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 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The maximum tolerated dose of oxaliplatin when delivered concurrently with 5-FU and external beam radiation in patients with locally advanced rectal adenocarcinomas (time frame: 7 days). The study lists 4 primary outcomes in all. 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 NCT00006094.

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 16 Jan 2013.