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AzTrials

Colorectal CancerPhase 2NCT00070434

S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum

A Phase 2 study testing capecitabine, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by SWOG Cancer Research Network.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, 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. 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?
capecitabine, fluorouracil and irinotecan hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2004to Feb 2006
Phase
Phase 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 confirmed primary adenocarcinoma of the rectum
  • Locally advanced disease (clinical T3-4, N0-2, M0) based on at least 1 of the following criteria:
  • Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall and/or sacrum
  • Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane is considered evidence of fixation
  • Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder invasion by cystoscopy and cytology or biopsy
  • Invasion into the prostate, vagina, or uterus
  • Transmural penetration of tumor through the muscularis propria as evidenced by CT scan or MRI and endorectal ultrasound
  • Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm of the anal verge) by proctoscopic examination
  • Measurable disease by x-ray, scans, or physical examination
  • Available tumor tissue to determine molecular profile of the tumor before study treatment
  • No clinical evidence of high-grade (lumen diameter < 1 cm) large bowel obstruction unless a diverting colostomy has been performed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,500/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • See Disease Characteristics
  • Creatinine ≤ 1.5 times ULN OR
  • Estimated creatinine clearance > 50 mL/min

Cardiovascular

  • No significant cardiac disease
  • No recent myocardial infarction

Gastrointestinal

  • See Disease Characteristics
  • Able to swallow oral medication
  • No active inflammatory bowel disease

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No prior unanticipated severe reaction to study drugs
  • No known dihydropyrimidine dehydrogenase deficiency
  • No serious uncontrolled infection
  • No other serious medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for colon or rectal cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior pelvic radiotherapy
  • No prior intra-operative radiotherapy or brachytherapy
  • No concurrent intra-operative radiotherapy or brachytherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • See Disease Characteristics
  • See Radiotherapy

About this study

Official title: A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients With Clinical T4 Rectal Cancer

RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, 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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of obtaining a pre-treatment determination of intratumoral molecular markers (TS, DPD, and ERCC-1) for use in selection of the appropriate regimen for induction cytotoxic combination chemotherapy in patients with cT3-4 rectal adenocarcinoma.
  • Determine the response probability (unconfirmed, complete and partial) in patients treated with targeted induction cytotoxic chemotherapy.
  • Determine the toxicity of targeted induction cytotoxic chemotherapy and chemoradiotherapy in these patients.
  • Determine the response probability in these patients treated with chemoradiotherapy.

OUTLINE: This is a multicenter study.

  • Induction chemotherapy: Patients are assigned to 1 of 3 treatment groups based on molecular analysis of the pretreatment tumor specimen.
  • Group I (lower likelihood of resistance to a fluorouracil-based regimen): Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1.
  • Group II (higher likelihood of resistance to a fluorouracil-based regimen): Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on day 1.
  • Group III (high likelihood of sensitivity to oxaliplatin and fluorouracil therapy): Patients receive oxaliplatin IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1.

Treatment in all groups repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are evaluated for response approximately 2 weeks after the completion of induction chemotherapy. Patients with stable disease or better receive chemoradiotherapy.

  • Chemoradiotherapy: Beginning approximately 3 weeks after the completion of induction chemotherapy, patients receive oral capecitabine twice daily continuously for 5 weeks and concurrent radiotherapy once daily 5 days a week for 5 weeks.

After chemoradiotherapy, patients may undergo attempted surgical resection at the discretion of the treating physician.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 10-65 patients will be accrued for this study.

Keywords
stage II rectal cancer, stage III rectal cancer, adenocarcinoma of the rectum
Medical subject headings
Colorectal Neoplasms, Rectal Neoplasms

What participants receive

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

  • capecitabineDrug

    825mg/m2 BID, PO, daily

  • fluorouracilDrug

    Bolus + IV for 46 hrs on Day 1

  • irinotecan hydrochlorideDrug

    IV infusion over 90 min on Day 1

  • leucovorin calciumDrug

    200mg/m2 IV 2 hour infusion on Day 1

  • oxaliplatinDrug

    85mg/m2 IV infusion for 90minutes on Day 1

  • radiation therapyRadiation

    Original Planning Target Volume (PTV1): The total dose to the prescription point shall be 4500 cGy in 25 fractions (Monday - Friday inclusive). Boost Planning Target Volume (PTV2): The cumulative dose within the boost volume to the prescription point shall be 5,040 - 5,400 cGy (per Section 7.5b). Daily Dose: The daily dose to the prescription point of the original and boost volumes shall be 180 cGy. Fractionation: Treatment shall be given 5 days/week. All radiation fields shall be treated once daily.

  • PyridoxineDrug

    50mg TID, PO daily

Study groups in NCT00070434
Study groupRoleWhat they receive
Irinotecan + 5-FU + LeucovorinExperimentalIrinotecan 180mg/m2, IV for 90min on Day 1, q 2 wk x 4 cycles; 5-FU 400 mg/m2, IV bolus on Day 1, q 2 wk x 4 cycles; 5-FU 2.4 g/m2 IV for 46 hours on Day 1, q 2 wk x 4 cycles; Leucovorin 200 mg/m2 IV for 2 hours on Day 1, q 2 wk x4 cycles.
Receives: Drug: capecitabine; Drug: fluorouracil; Drug: irinotecan hydrochloride; Drug: leucovorin calcium; Radiation: radiation therapy; Drug: Pyridoxine
Irinotecan + OxaliplatinExperimentalIrinotecan 175mg/m2 IV for 90 minutes on Day 1, q 2wk x4 cycles; Oxaliplatin 85mg/m2 IV for 2 hours on Day 1, q 2wk x4 cycles
Receives: Drug: capecitabine; Drug: irinotecan hydrochloride; Drug: oxaliplatin; Radiation: radiation therapy; Drug: Pyridoxine
Oxaliplatin + 5-FU + LeucovorinExperimentalOxaliplatin 85mg/m2 IV for 90 minutes on Day 1, q 2wk x4 cycles; 5-FU 400mg/m2 IV bolus on Day 1, q 2wk x4 cycles; 5-FU 2.4g/m2 IV for 46 hours on Day 1, q 2wk x4 cycles; Leucovorin 200mg/m2 IV for 2 hours on Day 1, q 2wk x4 cycles.
Receives: Drug: capecitabine; Drug: fluorouracil; Drug: leucovorin calcium; Drug: oxaliplatin; Radiation: radiation therapy; Drug: Pyridoxine

What is being measured

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

  1. Response (confirmed and unconfirmed response, complete response, partial response)

Timeline

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

  1. First posted7 Oct 2003 (estimated)
  2. Study startAug 2004
  3. Primary completionFeb 2006

Why it stopped: poor accrual

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070434
Sponsor's protocol ID
CDR0000334469
Other IDs
U10CA032102, S0304
Status last verified
Jun 2012
First submitted
3 Oct 2003
Last updated
7 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing capecitabine, fluorouracil and irinotecan hydrochloride in people with Colorectal Cancer, run by SWOG Cancer Research Network.

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: withdrawn, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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 was withdrawn before enrolling participants, so there are no results.

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?

Response (confirmed and unconfirmed response, complete response, partial response). 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 NCT00070434.

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 7 Jun 2012.

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Clinical Trial NCT00070434 | AzTrials