Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma

Cancer Clinical Trial

Official title:

A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705874
• Other study ID #: 47-01-002
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2008
• Last updated: January 22, 2012
• Start date: May 2006
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Progen Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated until the maximum tolerated dose is established.

Description:

This study will use a dose escalation design to determine the MTD of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. The dose of CGC-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. CGC-11047 will be administered IV over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted.

• measurable disease based on radiographic evaluation or elevated tumor markers.

• ECOG - 0 or 1 (KPS >70).

• Life expectancy > 3 months.

Exclusion Criteria:

• chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study

• known active brain metastases or leptomeningeal carcinomatosis.

• history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias

• clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• CGC-11047 and gemcitabine
Gemcitabine: (Closed to enrollment) 1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle. CGC-11047 will only be given on days 1 and 15 of each cycle and will start at dose level -1 (50 mg).
• CGC-11047 and docetaxel
Docetaxel: (Closed to enrollment) 75 mg/m2 administered IV over 60 minutes every 21 days. CGC-11047 will be administered only on Day 1 of each 21-day cycle and will start at dose level -1 (50 mg).
• CGC-11047 and bevacizumab
Bevacizumab: 5 mg/kg administered IV once every 14 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
• CGC-11047 and erlotinib
Erlotinib: 150 mg taken orally every day of each 28-day cycle. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
• CGC-11047 and cisplatin
Cisplatin: 80 mg/m2 administered IV over 1 hour once every 28 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
• CGC-11047 and 5-flurouracil / leucovorin
5-Flurouracil / Leucovorin: Leucovorin 500 mg/m2 IV over 2 hours with 5 - FU 500 mg/m2 IV bolus starting 1 hour into leucovorin infusion weekly for 6 wks, repeated every 56 days. CGC-11047 will be administered on Days 1, 8 and 15 of a 28 day cycle.
• CGC-11047 and sunitinib
Sunitinib: 50 mg orally once daily, 4 weeks on treatment followed by 2 weeks off (42 day cycle). CGC-11047 will be administered on Days 1 and 8 of a 21 day cycle.

Locations

Country	Name	City	State
United States	New York Oncology Hematology PC	Albany	New York
United States	Texas Oncology, PA	Dallas	Texas
United States	Rocky Mountain Cancer Centre	Denver	Colorado
United States	Cancer Centres of the Carolinas	Greenville	South Carolina
United States	Central Indiana Cancer Centres	Indianapolis	Indiana
United States	Dayton Oncology and Hematology, PA	Kettering	Ohio
United States	Comprehensive Cancer Centres of Nevada	Las Vegas	Nevada
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Cancer Centres of Florida	Ocoee	Florida
United States	Tyler Cancer Centre	Tyler	Texas
United States	Northwest Cancer Specialists - Vancouver Cancer Centre	Vancouver	Washington
United States	North Star Lodge Cancer Centre	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Progen Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).; DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047: Any nonhematologic toxicity > Grade 3 lasting > 3 days; Grade 4 thrombocytopenia; Grade 4 Anemia on the next scheduled dosing day; Grade 4 Neutropenia (lasting > than 5 days; Any febrile neutropenia (Grade 3 or 4)); Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity	End of Study	No
Secondary	Drug Safety		Ongoing	Yes
Secondary	Pharmacokinetics		End of Study	No

External Links

•   Progen Pharmaceuticals website