Clinical trial NCT00426582: Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Cancer
maximum tolerated dose
dose-limiting toxicity
patupilone
carboplatin
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6)
timeFrame: Every 3 weeks
Secondary outcomes:
measure: Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations
timeFrame: Every 6 weeks
measure: Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors)
timeFrame: Every 6 weeks
measure: Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response
timeFrame: Every 6 weeks
measure: Pharmacokinetic profile of patupilone combined with carboplatin
timeFrame: First 6 weeks (cycle 1 & 2 only)
measure: Relationship between pharmacokinetics and clinical outcome
timeFrame: Every 6 weeks during cycle 1 & cycle 2
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Rockville
country: United States
facility: Associates in Oncology
state: Maryland
city: Detroit
country: United States
facility: Wertz Clinical Cancer Center (Wayne State University)
state: Michigan
city: Saint Louis
country: United States
facility: Siteman Cancer Center (Washington University School of Medicine)
state: Missouri
city: Albuquerque
country: United States
facility: Cancer Research and Treatment Center (University of New Mexico)
state: New Mexico
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: