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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Progen Pharmaceuticals
• Treatments: Bevacizumab; Cisplatin; Docetaxel; Erlotinib Hydrochloride; Gemcitabine; Leucovorin; Sunitinib

Criteria

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.