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AzTrials

Pancreatic CancerPhase 3NCT00440167

Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

A Phase 3 study testing Gemcitabine, Capecitabine and Erlotinib in people with Pancreatic Cancer, run by PD Dr. med. Volker Heinemann.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine, Capecitabine and Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
No sites listed yet
Study dates
Jun 2006to Dec 2012
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years
  • Histologically proven pancreatic cancer stage III or IV (T1-3 N1M0 or T1 3N0 1M1)
  • No option for resection with curative intent
  • At least one measurable or not measurable lesion (according to RECIST)
  • No previous chemotherapy or other systemic tumor therapy
  • No previous radiation
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  • Performance-Status 0-2 according to WHO/ECOG
  • Life expectancy of at least 3 months
  • Adequate kidney-, liver- and bone marrow function, defined as
  • Absolute neutrophil count * 1,5 x 109/l
  • Hemoglobin * 8 g/dl
  • Thrombocytes * 100 x 109/l
  • Bilirubin * 2 x upper norm (with liver mets < 5-fold)
  • Serum Creatinine * 1,25 x upper norm
  • Creatinine clearance > 30 ml/min (Cockroft/Gault)
  • Transaminases * 2,5 x upper norm (with liver mets < 5-fold)
  • Possibility of regular long-term follow-up
  • Negative pregnancy test in women at childbearing age
  • All patients must have signed an informed consent before study entry.

Who cannot join

  • Known secondary cancer other than curatively treated basalioma or carcinoma in situ of the cervix uteri
  • Clinically unstable CNS-metastases
  • Known hypersensitivity against study medication
  • Severe impairment of renal function (creatinine clearance < 30 ml/min)
  • Severe impairment of liver function (bilirubin > 2,0 x above upper norm, transaminases > 2,5 x upper norm, or with known liver metastasis >5 x upper norm)
  • Clinically relevant disease of the cardiovascular system or other vital organs
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  • Known polyneuropathy
  • Known DPD-deficiency (screening not required)
  • Simultaneous treatment with the antiviral agent sorivudin or chemically related agents such as brivudin
  • Pregnancy, lactation or lack of reliable contraception in women at childbearing age
  • Mental disease, drug- or alcohol abuse
  • Participation in another clinical trial within the last 4 weeks
  • All other diseases which may prevent adequate participation in the trial
  • Indication of lack of compliance with study regulations

About this study

Official title: Randomized Phase III Trial With Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine in Patients With Advanced Pancreatic Cancer

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Keywords
capecitabine, gemcitabine, Erlotinib, pancreatic cancer, advanced
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • GemcitabineDrug

    Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28

  • CapecitabineDrug

    Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")

  • ErlotinibDrug

    Erlotinib 150 mg/d oral, daily without break

Study groups in NCT00440167
Study groupRoleWhat they receive
Arm AActive comparatorNot described
Receives: Drug: Capecitabine; Drug: Erlotinib
Arm BActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Erlotinib

What is being measured

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

  1. TTF2

    Time to treatment failure, after 2nd line (crossover) therapy

    Measured: approximate 6 months after first line treatment

Secondary outcomes (7)

  1. TTF1

    Time to treatment failure

    Measured: approximate 6 months after randomization

  2. Remission Rate

    Measured: approximate 6 months after randomization

  3. Overall Survival

    Measured: 42 months after randomization

  4. Clinical Benefit Response

    Measured: approximate 6 months after randomization

  5. Tumor marker CA19-9 characteristics

    Measured: approximate 6 months after randomization

  6. Quality of Life

    Measured: approximate 6 months after randomization

  7. Toxicity

    Measured: approximate 6 months after randomization

Timeline

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

  1. First posted26 Feb 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2011
  4. Study completionDec 2012 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00440167
Sponsor's protocol ID
RC-57 crossover
Status last verified
Jul 2012
First submitted
22 Feb 2007
Last updated
9 Jul 2012
Results posted
No

Publications

  • Weiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection? Clin Transl Oncol. 2024 May;26(5):1268-1272. doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4.

    PubMed 37794220

  • Guenther M, Surendran SA, Haas M, Heinemann V, von Bergwelt-Baildon M, Engel J, Werner J, Boeck S, Ormanns S. TPX2 expression as a negative predictor of gemcitabine efficacy in pancreatic cancer. Br J Cancer. 2023 Jul;129(1):175-182. doi: 10.1038/s41416-023-02295-x. Epub 2023 May 4.

    PubMed 37142730

  • Guenther M, Haas M, Heinemann V, Kruger S, Westphalen CB, von Bergwelt-Baildon M, Mayerle J, Werner J, Kirchner T, Boeck S, Ormanns S. Bacterial lipopolysaccharide as negative predictor of gemcitabine efficacy in advanced pancreatic cancer - translational results from the AIO-PK0104 Phase 3 study. Br J Cancer. 2020 Oct;123(9):1370-1376. doi: 10.1038/s41416-020-01029-7. Epub 2020 Aug 24.

    PubMed 32830200

  • Ormanns S, Siveke JT, Heinemann V, Haas M, Sipos B, Schlitter AM, Esposito I, Jung A, Laubender RP, Kruger S, Vehling-Kaiser U, Winkelmann C, Fischer von Weikersthal L, Clemens MR, Gauler TC, Marten A, Geissler M, Greten TF, Kirchner T, Boeck S. pERK, pAKT and p53 as tissue biomarkers in erlotinib-treated patients with advanced pancreatic cancer: a translational subgroup analysis from AIO-PK0104. BMC Cancer. 2014 Aug 28;14:624. doi: 10.1186/1471-2407-14-624.

    PubMed 25164437

  • Heinemann V, Vehling-Kaiser U, Waldschmidt D, Kettner E, Marten A, Winkelmann C, Klein S, Kojouharoff G, Gauler TC, von Weikersthal LF, Clemens MR, Geissler M, Greten TF, Hegewisch-Becker S, Rubanov O, Baake G, Hohler T, Ko YD, Jung A, Neugebauer S, Boeck S. Gemcitabine plus erlotinib followed by capecitabine versus capecitabine plus erlotinib followed by gemcitabine in advanced pancreatic cancer: final results of a randomised phase 3 trial of the 'Arbeitsgemeinschaft Internistische Onkologie' (AIO-PK0104). Gut. 2013 May;62(5):751-9. doi: 10.1136/gutjnl-2012-302759. Epub 2012 Jul 7.

    PubMed 22773551

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Capecitabine and Erlotinib in people with Pancreatic Cancer, run by PD Dr. med. Volker Heinemann.

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 19 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

TTF2 (time frame: approximate 6 months after first line treatment). 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 NCT00440167, which also lists 5 linked publications.

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 9 Jul 2012.

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