Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary
This study has been completed.
Sponsor:
TopoTarget A/S
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
TopoTarget A/S
ClinicalTrials.gov Identifier:
NCT00873119
First received: March 31, 2009
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.
| Condition | Intervention | Phase |
|---|---|---|
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Occult Primary |
Drug: belinostat, carboplatin, paclitaxel Drug: carboplatin, paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary |
Resource links provided by NLM:
Further study details as provided by TopoTarget A/S:
Primary Outcome Measures:
- Progression Free Survival measured by RECIST criteria [ Time Frame: May 2010 ] [ Designated as safety issue: No ]
| Enrollment: | 89 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Group A: belinostat administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
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Drug: belinostat, carboplatin, paclitaxel
Belinostat 1000 mg/m² IV infusion once daily for days 1+2+3 followed by belinostat 2000 mg PO on days 4+5 every 3 weeks in combination with carboplatin (AUC 6) IV infusion directly after paclitaxel (175 mg/m²) IV on day 3
Other Names:
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Active Comparator: B
Group B: paclitaxel administered as an IV infusion directly followed by carboplatin administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
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Drug: carboplatin, paclitaxel
Paclitaxel 175 mg/m² IV infusion followed by carboplatin (AUC 6) on day 1 of a 3-weekly cycle
Other Names:
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Detailed Description:
This is an open-label, multinational, multicenter, randomized, comparative efficacy and safety study in previously untreated patients with carcinoma of unknown primary. Patients meeting inclusion and exclusion criteria will be randomized to treatment within either of two study groups:
- Group A: belinostat administered as a 30 minute IV infusion once daily on days 1, 2 and 3 followed by belinostat administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
- Group B: paclitaxel administered as an IV infusion directly followed by carboplatin administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
Approximately 44 patients will be randomized to each group (in total 88 patients) over a planned recruitment period of 15 months. Patients will be treated in three week cycles for up to 6 cycles of chemotherapy containing treatment unless there is disease progression or treatment-related toxicities that are not manageable with dose-reduction schemes allowed per protocol or by other appropriate supportive measures. After 6 cycles of treatment, patients in Group A will continue treatment on belinostat monotherapy administered orally once daily on days 1 to 14, every 3-weeks until disease progression or treatment-related toxicities.
Toxicity will be monitored continuously during study treatment and 30 days following last study drug administration. Safety will be assessed by adverse events and laboratory tests, graded according to the NCI CTC (version 3.0).
Tumor assessments according to RECIST will be made by appropriate radiologic imaging techniques at baseline and by the same techniques every 6 weeks for the initial 6 months, then every 9 weeks for the next 6 months, then every 12 weeks for a further 12 months, and then every 6 months until 5 years from the start of study treatment cycle 1. When tumor assessments stop, survival follow-up will be carried out every 3 months for the initial 2 years, and then every 6 months until 5 years from the start of study treatment cycle 1.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Include
- Patients with carcinoma of unknown primary where the primary site had not been revealed by complete history, physical examination (including gynecological examination when appropriate), computed tomography scan of the chest, abdomen and pelvis, bilateral mammography (in women with adenocarcinoma or poorly differentiated carcinoma), routine laboratory studies (complete blood cell counts, electrolytes, urinalysis, liver and renal function tests), and directed work-up of any other symptomatic areas.
- Light microscopic pathologic diagnosis of adenocarcinoma (including poorly differentiated), squamous cell carcinoma, or poorly differentiated carcinoma.
- Signed consent of an IRB/Ethics committee approved informed consent form.
- At least one measurable lesion according to RECIST criteria.
- Performance status (ECOG) ≤ 2.
- Age ≥ 18 years.
- A negative serum or urine pregnancy test for women of childbearing potential. Postmenopausal women must have been amenorrheic for ≥ 12 months to be considered of non-childbearing potential.
- Acceptable liver, renal and bone marrow function.
Exclusion Criteria:
Include
- Patient with well recognized subsets of carcinoma of unknown primary site where treatments directed towards a defined tumor type, or surgery, alternatively radiotherapy, can be advised.
- Patients with brain or meningeal metastases. Note, patients with adequately treated brain metastases, e.g. surgically resected, or adequately controlled by radiotherapy, with no residual neurological symptoms due to metastases and no steroid treatment required, can be enrolled.
- Prior systemic anti-tumor therapy, including chemotherapy administered in association to radiotherapy for sensitization, for the carcinoma of unknown primary. Note, prior radiotherapy or surgery is allowed provided treatment was completed at least 4 weeks before randomization.
- Co-existing active severe infection or any co-existing medical condition assessed by the investigator as likely to interfere with trial procedures.
- Significant cardiovascular disease
- History of a previous malignancy within 5 years with the exception of non-metastatic non-melanoma skin cancer or cervical carcinoma in situ. Prior systemic therapy for other malignancy completed at least 5 years before randomization is allowed.
- Known infection with HIV, or known active Hepatitis B or C infection.
- Peripheral neuropathy ≥ Grade 2.
- Pregnant, or lactating, females.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873119
Locations
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33619 | |
| United States, Georgia | |
| Northwest Georgia Oncology Centers | |
| Marietta, Georgia, United States, 30060 | |
| United States, Louisiana | |
| Baton Rouge Medical Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Center for Cancers and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Missouri | |
| Research Medical Center | |
| Kansas City, Missouri, United States, 64132 | |
| United States, Ohio | |
| Oncology Hematology Care Inc. | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, South Carolina | |
| South Carolina Oncology Associates | |
| Columbia, South Carolina, United States, 29210 | |
| United States, Tennessee | |
| Chattanooga Oncology & Hematology Associates, PC | |
| Chattanooga, Tennessee, United States, 37404 | |
| Tennessee Oncology Sarah Cannon Research | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| South Texas Oncology and Hematology | |
| San Antonio, Texas, United States, 78258 | |
| United States, Virginia | |
| Virginia Cancer Institute | |
| Richmond, Virginia, United States, 23230 | |
| Denmark | |
| H:S Rigshospital, The Finsen Centre | |
| Copenhagen, Denmark, DK-2100 | |
| France | |
| CRLCC Francois Baclesse, Oncologie medicale | |
| Caen, France, 14000 | |
| Centre Oscar Lambert | |
| Lille, France, 59020 | |
| Centre Léon Bérard, Oncologie | |
| Lyon, France, 69008 | |
| Centre Eugène Marquis | |
| Rennes cedex, France, 35042 | |
| Centre Henri Becquerel, Oncologie Médicale | |
| Rouen, France, 76038 | |
| Institut de Cancerologie de la Loire | |
| Saint Priest en Jarez, France, 42270 | |
| Institut Gustave Roussy IGR | |
| Villejuif cedex, France, 94805 | |
| Germany | |
| Carl-Gustav-Carus Medicinische Klinik und Poliklinik I | |
| Dresden, Germany, 01307 | |
| Kliniken Essen-Mitte | |
| Essen, Germany, 45136 | |
| ASKLEPIOS Klinik Altona | |
| Hamburg, Germany, 22763 | |
| Ostholstein-Onkologie | |
| Oldenburg in Holstein, Germany, 23758 | |
Sponsors and Collaborators
TopoTarget A/S
Spectrum Pharmaceuticals, Inc
Investigators
| Principal Investigator: | Seaborn Wade, MD | Virginia Cancer Institute - USA |
| Principal Investigator: | John Hainsworth, MD | Tennessee Oncology Sarah Cannon Research Institute - USA |
| Principal Investigator: | Gerdt Hübner, MD | Ostholstein-onkologie-Onkologische Schwerpunktpraxis - Germany |
| Principal Investigator: | Michael Stahl, MD | Kliniken Essen-Mitte - Germany |
| Principal Investigator: | Karim Fizazi, MD | Institut Gustave Roussy IGR - France |
| Principal Investigator: | Pascal Seve, MD | Hôpital de l'Hôtel-Dieu - Lyon, France |
| Principal Investigator: | Thierry Lesimple, MD | Comprehensive Cancer Center Eugène Marquis - Rennes Cedex, France |
| Principal Investigator: | Gedske Daugaard, MD | H:S Rigshospitalet, Department of Oncology - Denmark |
| Principal Investigator: | James Rubinsak, MD | Florida Cancer Specialists - USA |
| Principal Investigator: | Djelila Allouache, MD | Centre Francois Baclesse - Caen, France |
| Principal Investigator: | Edward Arrowsmith, MD | Chattanooga Oncology & Hematology Associates, PC - USA |
| Principal Investigator: | Christelle De La Fouchardiere, MD | Centre Léon Bérard - Lyon, France |
| Principal Investigator: | Marianne Leheurteur, MD | Centre Henri Becquerel - Rouen, France |
| Principal Investigator: | Christian Meyer zum Büschenfelde, MD | ASKLEPIOS Klinik Altona - Hamburg, Germany |
| Principal Investigator: | Nicolas Penel, MD | Centre Oscar Lambret, Lille, France |
| Principal Investigator: | Fred Kudrik, MD | South Carolina Oncology Associates, SC, USA |
| Principal Investigator: | Robert Herman, MD | Northwest Georgia Oncology Centers, P.C. USA |
| Principal Investigator: | Gladys Rodriquez, MD | South Texas Oncology and Hematology, San Antonio, USA |
| Principal Investigator: | Irfan Firdaus, MD | Oncology Hematology Care, Inc, Cincinnati, USA |
| Principal Investigator: | Ralph Boccia, MD | Center for Cancers and Blood disorders, Bethesda, USA |
| Principal Investigator: | Michael Castine, MD | Baton |
| Principal Investigator: | Jaswinder Singh | Research Medical Center, Kansas City, USA |
| Principal Investigator: | Gunnar Folprecht, MD | Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Germany |
| Principal Investigator: | Yacine Merrouche, Prof | Institut de Cancerologie de la Loire |
More Information
No publications provided
| Responsible Party: | TopoTarget A/S |
| ClinicalTrials.gov Identifier: | NCT00873119 History of Changes |
| Other Study ID Numbers: | PXD101-CLN-17 |
| Study First Received: | March 31, 2009 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by TopoTarget A/S:
|
Belinostat PXD101 Carboplatin Paclitaxel |
CUP Carcinoma of unknown primary Occult primary |
Additional relevant MeSH terms:
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Carcinoma Neoplasms, Unknown Primary Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Carboplatin |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013