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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: CGC-11047 and bevacizumab; Drug: CGC-11047 and docetaxel; Drug: CGC-11047 and sunitinib; Drug: CGC-11047 and erlotinib; Drug: CGC-11047 and cisplatin; Drug: CGC-11047 and gemcitabine; Drug: CGC-11047 and 5-flurouracil / leucovorin

• Registration Number: NCT00705874
• Lead Sponsor: Progen Pharmaceuticals

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Results First Submitted: 2011-11-17
• Results First Submitted QC: 2012-01-22
• Results First Posted: 2012-02-27
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	CGC-11047 and bevacizumab	CGC-11047 in combination with Bevacizumab
2	CGC-11047 and docetaxel	CGC-11047 in combination with Docetaxel
7	CGC-11047 and sunitinib	CGC-11047 in combination with Sunitinib
4	CGC-11047 and erlotinib	CGC-11047 in combination with Erlotinib
5	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.
1	CGC-11047 and gemcitabine	CGC-11047 in combination with Gemcitabine
6	CGC-11047 and 5-flurouracil / leucovorin	CGC-11047 in combination with 5-Flurouracil / Leucovorin

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	End of Study	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: 1. Any nonhematologic toxicity \> Grade 3 lasting \> 3 days; 2. Grade 4 thrombocytopenia; 3. Grade 4 Anemia on the next scheduled dosing day; 4. Grade 4 Neutropenia (lasting \> than 5 days; 5. Any febrile neutropenia (Grade 3 or 4)); 6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity

Secondary Outcome Measures

Name	Time	Method
Drug Safety	Ongoing
Pharmacokinetics	End of Study

Trial Locations

Locations (12)

Cancer Centres of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

North Star Lodge Cancer Centre; 🇺🇸 Yakima, Washington, United States

Northwest Cancer Specialists - Vancouver Cancer Centre; 🇺🇸 Vancouver, Washington, United States

Rocky Mountain Cancer Centre; 🇺🇸 Denver, Colorado, United States

New York Oncology Hematology PC; 🇺🇸 Albany, New York, United States

Dayton Oncology and Hematology, PA; 🇺🇸 Kettering, Ohio, United States

Texas Oncology, PA; 🇺🇸 Dallas, Texas, United States

Central Indiana Cancer Centres; 🇺🇸 Indianapolis, Indiana, United States

Cancer Centres of Florida; 🇺🇸 Ocoee, Florida, United States

Comprehensive Cancer Centres of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Tyler Cancer Centre; 🇺🇸 Tyler, Texas, United States