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CholangiocarcinomaPhase 2GemOx-PDTNCT00713687

Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma

A Phase 2 study testing Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®) in people with Cholangiocarcinoma, run by Technical University of Munich at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Cholangiocarcinoma
What is being tested?
Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteGermany
Study dates
Aug 2008to Dec 2011
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in >= 2 diagnostic methods
  • Bile duct stenoses which are technically successful treated with biliary drainage
  • Irresectability/inoperability
  • Karnofsky-Index >= 60%
  • Age >= 18
  • Written consent
Show all 14Show fewer
  • Before chemotherapy:
  • Bilirubin <= 5 mg/dl
  • GOT/GPT < 5x upper standard
  • Creatinine < 2x upper standard
  • Thrombocytes > 100 G/l
  • Neutrophils > 2,00 G/l
  • Haemoglobin > 9 g/dl
  • No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)

Who cannot join

  • Implantation of a metal stent in the bile duct
  • Previous PDT or chemotherapy
  • Neoplasia
  • Porphyria
  • Pregnant or breastfeeding women
  • Women of childbearing age and potent men who are not using highly effective contraceptives

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Technical University of Munich at the Klinikum rechts der Isar II. Medizinische Klinik Ismaninger Str. 22

    Munich, 81675

Other trials in Germany

About this study

Official title: Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma

In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.

Read the detailed description

Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.

Being tested
Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)
Keywords
photodynamic therapy, PDT, gemcitabine, oxaliplatin, cholangiocarcinoma
Medical subject headings
Cholangiocarcinoma

What participants receive

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

  • Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)Drug

    Also called No other names

    1. Photodynamic therapy (PDT) after successful drainage: Photosan® 2 mg/kg i.v. 48 hrs before laser activation
    2. 9 cycles of GemOx chemotherapy (start 4 weeks after PDT):
    • Gemcitabine 1000 mg/m² 100 min infusion on day 1 of chemotherapy
    • Oxaliplatin 100 mg/m² 2h infusion on day 2 of chemotherapy
    • iteration every 14 days
    • afterwards 4 weeks intermission
    1. Iteration of 1. and 2. in case of good compatibility
Study groups in NCT00713687
Study groupRoleWhat they receive
1ExperimentalTreatment by combination of photodynamic therapy and chemotherapy
Receives: Drug: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®)

What is being measured

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

  1. Progression free survival 6 months after study start

    Measured: 6 months after study start

Secondary outcomes (1)

  1. Progression free survival 12 months after study start Progression free interval Overall survival Life quality

    Measured: Until 12 months after study start

Timeline

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

  1. First posted11 Jul 2008 (estimated)
  2. Study startAug 2008
  3. Study completionDec 2011

Why it stopped: recruiting failed

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
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00713687
Sponsor's protocol ID
GEM-658-EBE-0024-I
Other IDs
EudraCT-Nr.: 2008-001560-37
Acronym
GemOx-PDT
Status last verified
Jul 2008
First submitted
7 Jul 2008
Last updated
10 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • Rajagopalan V, Daines WP, Grossbard ML, Kozuch P. Gallbladder and biliary tract carcinoma: A comprehensive update, Part 1. Oncology 2004;18:889-896. Patel T. Cholangiocarcinoma. Nat Clin Pract Gastroenterol Hepatol 2006;3:33-42. de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999;341:1368-1378. Eckel F, Schmid RM. Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials. Br J Cancer 2007;96:896-902. Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mössner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology 2003;125:1355-1363. Zoepf T, Jakobs R, Arnold JC, Apel D, Riemann JF. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol 2005;100:2426-2430. Wiedmann M, Caca K, Berr F, Schiefke I, Tannapfel A, Wittekind C, Mössner J, Hauss J, Witzigmann H. Neoadjuvant photodynamic therapy as a new approach to treating hilar cholangiocarcinoma: a phase II pilot study. Cancer. 2003;97:2783-2790. Dougherty TJ, Gomer CJ, Henderson BW, Jori G, Kessel D, Korbelik M, Moan J, Peng Q. Photodynamic therapy. J Natl Cancer Inst. 1998;90:889-905. Gollnick SO, Vaughan L, Henderson BW. Generation of effective antitumor vaccines using photodynamic therapy. Cancer Res 2002;62:1604-1608. Wiedmann M, Berr F, Schiefke I, Witzigmann H, Kohlhaw K, Mössner J, Caca K. Photodynamic therapy in patients with non-resectable hilar cholangiocarcinoma: 5-year follow-up of a prospective phase II study. Gastrointest Endosc 2004;60:68-75.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®) in people with Cholangiocarcinoma, run by Technical University of Munich at 1 site 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 14 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 Aug 2012. 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 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. 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?

Progression free survival 6 months after study start (time frame: 6 months after study start). 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 NCT00713687, 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 10 Aug 2012.

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