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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

Phase 2
18 Years
Not Enrolling
Occult Primary

Thank you

Trial Information

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

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.

Inclusion Criteria:


- 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:


- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival measured by RECIST criteria

Outcome Time Frame:

May 2010

Safety Issue:


Principal Investigator

Seaborn Wade, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Cancer Institute - USA


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

December 2012

Related Keywords:

  • Occult Primary
  • Belinostat
  • PXD101
  • Carboplatin
  • Paclitaxel
  • CUP
  • Carcinoma of unknown primary
  • Occult primary
  • Carcinoma
  • Neoplasms, Unknown Primary



South Texas Oncology and HematologySan Antonio, Texas  78229
Florida Cancer SpecialistsFort Myers, Florida  33901
Research Medical CenterKansas City, Missouri  64132
South Carolina Oncology AssociatesColumbia, South Carolina  29201
Oncology Hematology Care Inc.Cincinnati, Ohio  45242
Virginia Cancer InstituteRichmond, Virginia  23230
Northwest Georgia Oncology CentersMarietta, Georgia  30060
Chattanooga Oncology & Hematology Associates, PCChattanooga, Tennessee  37404
Center for Cancers and Blood DisordersBethesda, Maryland  20817
Tennessee Oncology Sarah Cannon ResearchNashville, Tennessee  37203
Baton Rouge Medical CenterBaton Rouge, Louisiana  70809