Combination Trial of Patupilone and Carboplatin in Adult Patients With Advanced Solid Tumors

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00426582

Collaborator

(none)

Enrollment

Locations

Arms

9.6

Patients Per Site

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: Patupilone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of patupilone in combination with carboplatin (AUC 6) [Every 3 weeks]

Secondary Outcome Measures

Safety of patupilone combined with carboplatin assessed by adverse events, serious adverse events, laboratory values and physical examinations [Every 6 weeks]
Overall response rate (complete and partial response; CR + PR) according to RECIST (response evaluation criteria in solid tumors) [Every 6 weeks]
Time to progression (TTP), duration of overall response, duration of stable disease and time to overall response [Every 6 weeks]
Pharmacokinetic profile of patupilone combined with carboplatin [First 6 weeks (cycle 1 & 2 only)]
Relationship between pharmacokinetics and clinical outcome [Every 6 weeks during cycle 1 & cycle 2]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Norwalk Hospital	Norwalk	Connecticut	United States	06856
2	Associates in Oncology	Rockville	Maryland	United States	20850
3	Wertz Clinical Cancer Center (Wayne State University)	Detroit	Michigan	United States	48201
4	Siteman Cancer Center (Washington University School of Medicine)	Saint Louis	Missouri	United States	63110-1093
5	Cancer Research and Treatment Center (University of New Mexico)	Albuquerque	New Mexico	United States	87131