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

Progen Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: CGC-11047 and sunitinib; Drug: CGC-11047 and cisplatin; Drug: CGC-11047 and gemcitabine; Drug: CGC-11047 and bevacizumab; Drug: CGC-11047 and 5-flurouracil / leucovorin; Drug: CGC-11047 and erlotinib; Drug: CGC-11047 and docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00705874

47-01-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 7 patient groups

1

Experimental group

Description:

CGC-11047 in combination with Gemcitabine

Treatment:

Drug: CGC-11047 and gemcitabine

2

Experimental group

Description:

CGC-11047 in combination with Docetaxel

Treatment:

Drug: CGC-11047 and docetaxel

3

Experimental group

Description:

CGC-11047 in combination with Bevacizumab

Treatment:

Drug: CGC-11047 and bevacizumab

4

Experimental group

Description:

CGC-11047 in combination with Erlotinib

Treatment:

Drug: CGC-11047 and erlotinib

5

Experimental group

Description:

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.

Treatment:

Drug: CGC-11047 and cisplatin

6

Experimental group

Description:

CGC-11047 in combination with 5-Flurouracil / Leucovorin

Treatment:

Drug: CGC-11047 and 5-flurouracil / leucovorin

7

Experimental group

Description:

CGC-11047 in combination with Sunitinib

Treatment:

Drug: CGC-11047 and sunitinib