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Colorectal CarcinomaPhase 2NCT01418742

SKIP - A Double-blind Placebo-controlled Randomized Multicenter Trial of Skin Toxicity Treatment

A Phase 2 study testing Panitumumab in people with Colorectal Carcinoma, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 12 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Panitumumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
12 sitesGermany
Study dates
Aug 2011to May 2013
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

  • Patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated (wild-type) KRAS who are planned to receive treatment with panitumumab monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens and without prior treatment with epidermal growth factor receptor (EGFR) antibody
  • Man or woman 18 years of age or older
  • Signed and dated informed consent before the start of specific protocol procedures
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2
  • Bilirubin ≤ 1.5 x ULN, SGOT/SGPT ≤ 2.5 x ULN, AP ≤ 3 x ULN if no evidence of liver metastases or Bilirubin ≤ 3 x ULN, SGOT/SGPT ≤ 5 x ULN, AP ≤ 5 x ULN if evidence of liver metastases
  • Women of child-bearing potential have to use adequate highly effective methods of contraception . Since doxycyline may reduce efficacy of hormonal contraceptives, women of child-bearing potential have to use double-barrier methods within 4 weeks before first intake of study medication, during study participation and at least 6 weeks after last intake of study medication even if using hormonal contraceptives Women are considered to be of child-bearing potential unless they are ≥ 50 years old and for more than 2 years amenorrheic or unless they are surgically sterile.

Who cannot join

  • Absence of any of the above-listed inclusion criteria
  • Any serious medical condition or psychiatric illness that would interfere with the patient's ability to sign the informed consent form.
  • Allergic reaction to one of the medications to be used
  • Subject allergic to panitumumab or any components of the panitumumab formulation or treatment regimen
  • Prior treatment with EGFR antibody
  • CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampicin, rifabutin, and St. John's Wort) ≤ 2 weeks before randomization (itraconazole should be used with caution)
Show all 13Show fewer
  • Subjects with hypersensitivity to doxycycline, other tetracyclines, or ingredients of doxycycline capsules
  • Systemic treatment with antibiotics which was completed less than 7 days prior to randomization
  • Pregnant and/or breast-feeding women
  • Active participation in other clinical studies in the previous 4 weeks
  • Serious liver function disorders
  • History of, or evidence of, interstitial pneumonitis or pulmonary fibrosis
  • Person who has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • DRK Kliniken Berlin / Köpenick, Klinik für Chirurgie

    Berlin, 12559

  • Onkologische Schwerpunktpraxis

    Berlin, 13055

  • Medizinisches Versorgungszentrum Ärzteforum Seestraße

    Berlin, 13347

  • Charité Campus Virchow Klinikum (CVK), Centrum für Tumormedizin, Medizinische Klinik mit Schwerpunkt Hämatologie u. Onkologie

    Berlin, 13355

  • Ärzteforum Bernau

    Bernau, 16321

  • Onkologische Schwerpunktpraxis

    Brandenburg, 14770

  • Städtisches Klinikum Dessau, Hömatologie und Internistische Onkologie

    Dessau, 06847

  • St. Georg Klinikum Eisenach gGmbH, Klinik für Innere Medizin 2

    Eisenach, 99817

  • Krankenhaus St. Elisabeth u. St. Barbara, Klinik für Allgemein- u. Visceralchirurgie

    Halle, 06110

  • Ärzteforum Hennigsdorf

    Hennigsdorf, 16761

  • eps-early phase GmbH

    Jena, 07743

  • Klinikum Dorothea Christiane Erxleben Quedlinburg gGmbH, Klinik f. Allgemein, Vizeral- und Gefäßchirurgie

    Quedlinburg, 06484

Other trials in Germany

About this study

Official title: SKIP - A Double-blind Placebo-controlled Randomized Multicenter Phase II Trial of Skin Toxicity Treatment in Subjects With Advanced or Metastatic Colorectal Carcinoma Receiving Panitumumab

Skin toxicity treatment in patients with advanced or metastatic colorectal cancer (mCRC) and non-mutated (wild-type) KRAS treated with panitumumab monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Read the detailed description

Because of their frequency and severity panitumumab associated skin toxicities affect patients' quality of life and thus threaten patients' compliance to therapy. There is an urgent need for evidence-based treatment recommendations for the prevention and management of panitumumab -associated skin toxicities.

The study aims to compare the efficacy and safety of a manageable preemptive treatment with oral doxycycline in combination with a supportive topical regimen containing erythromycin cream (2 %) over duration of 12 weeks on the occurrence and grade of panitumumab induced skin toxicities in a double-blind, controlled randomized setting. Basic skin treatment with or without doxycycline will be discontinued at the end of study treatment after 12 weeks or until a value of 6-10 is observed on the visual analogue scale (VAS), whichever is sooner.

Being tested
Panitumumab, Doxycycline/Placebo, Panitumumab
Keywords
skin toxicity
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, Doxycycline/PlaceboDrug

    comparison of Doxycyline/Placebo and Panitumumab regarding efficacy of the therapy of panitumumab induced skin toxicity

  • PanitumumabDrug

    mCRC patients receiving panitumumab as EGFR inhibitor.

Study groups in NCT01418742
Study groupRoleWhat they receive
Doxycycline 100 mg BID oral useActive comparatorNot described
Receives: Drug: Panitumumab, Doxycycline/Placebo
Placebo 100 mg BID oral usePlacebo comparatorNot described
Receives: Drug: Panitumumab

What is being measured

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

  1. Time until unblinding of skin therapy allocation (basic skin treatment with or without doxycycline) due to insufficient efficacy (i.e. unbearable skin toxicity, measured by patient's allocating point 6 through 10 on a visual analogue scale)

    Measured: 30 month

Secondary outcomes (13)

  1. Incidence of specific ≥ grade 2 skin toxicities over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner

    Measured: 30 months

  2. Time to first occurrence of specific ≥ grade 2 skin toxicities

    Measured: 30 months

  3. Most severe specific ≥ grade 3 skin toxicities of interest over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner

    Measured: 30 months

  4. Time to the first most severe specific ≥ grade 3 skin toxicities

    Measured: 30 month

  5. Incidence of panitumumab dose reduction due to the specific skin toxicities of interest over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner

    Measured: 30 month

  6. Scores in DLQI under preemptive basic skin treatment with or without doxycycline

    Measured: 30month

  7. Incidence of doxycycline related adverse events

    Measured: 30 month

  8. Type of panitumumab related adverse events

    Measured: 30 month

  9. Response rate to panitumumab over 12 weeks or until a value of 6-10 is observed on the VAS, whichever is sooner (only if patient received at least 8 weeks of study treatment)

    Measured: 30 month

  10. Type of doxycycline related adverse events

    Measured: 30 month

  11. Severity of doxycycline related adverse events

    Measured: 30 month

  12. Incidence of panitumumab related adverse events

    Measured: 30 month

  13. Severity of panitumumab related adverse events

    Measured: 30 month

Timeline

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

  1. First posted17 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMay 2013
  4. Study completionMay 2013

Why it stopped: Recruitement did not meet expectations. Prev. differentiation of RAS-wild-type and mutated RAS are not in accordance with the scientific rank anymore.

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01418742
Sponsor's protocol ID
GMIHO-010/2009
Status last verified
Mar 2013
First submitted
3 Aug 2011
Last updated
14 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab in people with Colorectal Carcinoma, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 12 sites in Germany.

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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Jul 2014. 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 Germany. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Recruitement did not meet expectations. Prev. differentiation of RAS-wild-type and mutated RAS are not in accordance with the scientific rank anymore.). Results are not available in the source record.

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?

Time until unblinding of skin therapy allocation (basic skin treatment with or without doxycycline) due to insufficient efficacy (i.e. unbearable skin toxicity, measured by patient's allocating point 6 through 10 on a visual analogue scale) (time frame: 30 month). 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 NCT01418742.

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 14 Jul 2014.

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