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Metastatic Colorectal CancerPhase 2NCT00475293

Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With mCRC

A Phase 2 study testing Panitumumab and CPT-11 in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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

The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Panitumumab and CPT-11
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteSpain
Study dates
May 2007to Mar 2010
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

Who may be able to join

  • Man or woman > 18 years of age
  • Competent to comprehend, sign, and date an IEC-approved informed consent form
  • Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or rectum.
  • Radiographically documented disease progression per modified RECIST criteria either while receiving or ≤ 6 months after the last dose of prior first-line chemotherapy for mCRC
  • At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria.
  • If subject has prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or active disease within 5 years.
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  • Prior radiotherapy is acceptable.
  • One and only one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy.
  • ECOG performance status of 0, 1 or 2
  • Life expectancy ≥ 3 months
  • Hematologic function:ANC > 1.5 x 109/L, Platelet count > 100 x 109/L, Hemoglobin > 10 g/dL
  • Renal function: Creatinine < 1.5 mg/dL
  • Hepatic function: AST and ALT < 3 x ULN (if liver metastases < 5 x ULN)
  • Bilirubin < 2 x ULN

Who cannot join

  • No more than one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based chemotherapy is allowed)
  • Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months prior to enrolment.
  • Systemic chemotherapy, hormonal therapy, immunotherapy or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before inclusion
  • Unresolved toxicities from prior systemic therapy that, in the opinion of the investigator, does not qualify the patient for inclusion
  • Central nervous system/brain metastases
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
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  • Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib)
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
  • Treatment for systemic infection within 14 days before initiating study treatment
  • Radiotherapy ≤ 14 days prior to inclusion. Patients must have recovered from all radiotherapy-related toxicities
  • Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day)
  • History of Gilbert's syndrome or dihydropyrimidine deficiency
  • History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results
  • Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
  • subject allergic to the ingredients of the study medication or to Staphylococcus protein A
  • Any co-morbid disease that would increase risk of toxicity
  • Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
  • Any investigational agent within 30 days before enrolment
  • Must not have had a major surgical procedure within 28 days of randomization
  • Subject who is pregnant or breast feeding
  • Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods
  • Subject unwilling or unable to comply with study requirements

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Spanish Cooperative Group for Gastrointestinal Tumour Therapy

    Madrid, 28046

Other trials in Spain

About this study

Official title: A Phase 2 Clinical Trial of Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With Metastatic Colorectal Cancer

The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC).

Read the detailed description

Aside from limited cases of resectable metastatic disease, mCRC cannot be cured with the currently available chemotherapy regimens, and there is a continued need to improve the current treatment.

Panitumumab has demonstrated objective tumour response, increase in progression free survival and has an acceptable safety profile in clinical studies in patients with metastatic colorectal cancer when used as a monotherapy or in combination with irinotecan (Meropol et al, 2003; Berlin et al, 2004; Hecht et al, 2004; Malik et al, 2005).

The addition of panitumumab to chemotherapy is expected to enhance the treatment effect of chemotherapy.

This is a Phase II, single-arm, multi-centre study. Eligible subjects will be enrolled and treated with second-line combination therapy consisting of panitumumab and irinotecan.

Prior to study entry and in order to confirm eligibility, the investigator or designee will review existing radiological images in addition to any other relevant clinical documents (reports, notes, etc.) to ensure the subject has failed or relapsed while on or after one prior chemotherapy regimen.

Panitumumab will be administered by intravenous (IV) infusion at a dose of 9 mg/kg once Q3W. Irinotecan chemotherapy (350 mg/m2) will be administered after the administration of panitumumab. Subjects will be permitted to receive panitumumab and chemotherapy until he or she develops disease progression (PD) or experiences unacceptable toxicities. Subjects who discontinue irinotecan, for example due to toxicity, will be permitted to receive panitumumab monotherapy. After discontinuation of panitumumab, the treatment period will end and subjects will attend a safety follow-up visit 56 ±3 days later.

Tumour response assessment will be performed by the investigator per the modified Response Evaluation Criteria in Solid Tumours (m-RECIST). Subjects will be evaluated for tumour response every 9 weeks ± 1 week until PD or withdrawal from the trial. Responding disease will be confirmed no less than 28 days after the criteria for response are first met. Subjects with symptoms suggestive of PD should be evaluated for tumour progression at the time the symptoms occur.

Subjects will complete an EQ-5D PRO questionnaire every 6 weeks ± 1 week, from baseline through to the end of the treatment period and at the safety follow-up visit.

Being tested
Panitumumab and CPT-11
Keywords
metastatic colorectal cancer, 2nd-line Therapy, panitumumab, irinotecan
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Panitumumab and CPT-11Drug

    Panitumumab will be administered by IV infusion on day 1 of each cycle just prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg

    Irinotecan: 350 or 300 mg/m2. day 1

    One treatment cycle is defined as the 21 day period following the commencement of treatment with panitumumab + irinotecan plus additional time, as needed, for the resolution of irinotecan-related toxicities

Study groups in NCT00475293
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Panitumumab and CPT-11

What is being measured

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

  1. objective response rate

    Measured: 2007-2010

Secondary outcomes (2)

  1. disease control rate, duration of response, time to response, progression-free survival, time to progression,time to treatment failure,duration of stable disease

    Measured: 2007-2010

  2. adverse events

    Measured: 2007-2010

Timeline

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

  1. First posted21 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionMar 2010
  4. Study completionMar 2010

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475293
Sponsor's protocol ID
TTD-06-04
Status last verified
Feb 2013
First submitted
17 May 2007
Last updated
13 Sep 2013
Results posted
No
Data monitoring committee
No

Publications

  • Carrato A, Gomez A, Escudero P, Chaves M, Rivera F, Marcuello E, Gonzalez E, Gravalos C, Constenla M, Manzano JL, Losa F, Maurel J, Duenas R, Massuti B, Gallego J, Aparicio J, Anton A, Aranda E. Panitumumab and irinotecan every 3 weeks is an active and convenient regimen for second-line treatment of patients with wild-type K-RAS metastatic colorectal cancer. Clin Transl Oncol. 2013 Sep;15(9):705-11. doi: 10.1007/s12094-012-0993-x. Epub 2013 Jan 29.

    PubMed 23359181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab and CPT-11 in people with Metastatic Colorectal Cancer, run by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) at 1 site in Spain.

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 14 inclusion and 22 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 13 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 1 site in Spain. 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 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 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?

objective response rate (time frame: 2007-2010). 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 NCT00475293, 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 13 Sep 2013.

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