Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors - Full Text View

Purpose

This study will evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone combined with carboplatin in adult patients with advanced solid tumors who progressed despite standard therapy or for whom no standard therapy exists or who might benefit from treatment with carboplatin

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: Patupilone	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase Ib, Multicenter, Open-label, Dose-finding Study of Patupilone Administered Intravenously Every 3 Weeks in Combination With Carboplatin AUC 6 in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
Pharmacokinetic profile of patupilone combined with carboplatin [ Time Frame: First 6 weeks (cycle 1 & 2 only) ] [ Designated as safety issue: No ]
Relationship between pharmacokinetics and clinical outcome [ Time Frame: Every 6 weeks during cycle 1 & cycle 2 ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	August 2006
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Patupilone only Cycle 1 patupilone alone Cycle 2 and onward patupilone and carboplatin	Drug: Patupilone
Active Comparator: Carboplatin alone Cycle 1 Carboplatin alone Cycle 2 and onward patuilone and carboplatin	Drug: Patupilone

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, or for whom no standard therapy exists, or who might benefit from treatment with carboplatin
A minimum of 4 weeks since the last treatment with chemotherapy
WHO Performance Status 0 (able to carry out all normal activity without restriction) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out work)
Age ≥ 18
Adequate hematological parameters
No major impairment of renal or hepatic function
Written informed consent obtained

Exclusion criteria:

Major surgery less than 4 weeks prior to study entry and/or not fully recovered from surgery
Chemotherapy or investigational compound less than 4 weeks prior to study entry, or planned while participating in the study
Prior administration of an epothilone
Hypersensitivity to carboplatin. Patients resistant to carboplatin are not recommended to enter the trial
Radiotherapy (RT) less than 4 weeks prior to study entry (except for palliative therapy of distant metastases), or planned RT while participating in the study
Diarrhea within 7 days prior to start of treatment. Unresolved bowel obstruction
Peripheral neuropathy > Grade 1 (mild)
Symptomatic brain metastases
Colostomy

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426582

Locations

United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Maryland
Associates in Oncology
Rockville, Maryland, United States, 20850
United States, Michigan
Wertz Clinical Cancer Center (Wayne State University)
Detroit, Michigan, United States, 48201
United States, Missouri
Siteman Cancer Center (Washington University School of Medicine)
St. Louis, Missouri, United States, 63110-1093
United States, New Mexico
Cancer Research and Treatment Center (University of New Mexico)
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis Pharmeceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00426582 History of Changes
Other Study ID Numbers:	CEPO906A2105
Study First Received:	January 24, 2007
Last Updated:	March 24, 2011
Health Authority:	United States: Food and Drug Administration France: Agence Francaise de Securite Sanitaire des Aliments (AFSSA; Agency for Food Safety)

Keywords provided by Novartis:

Cancer
maximum tolerated dose
dose-limiting toxicity

patupilone
carboplatin
pharmacokinetics

Additional relevant MeSH terms:

Neoplasms
Epothilone B
Carboplatin
Epothilones
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013