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
Condition: Cancer
MeSH terms: Lymphoma
Intervention: CGC-11047 and gemcitabine; CGC-11047 and docetaxel; CGC-11047 and bevacizumab; CGC-11047 and erlotinib; CGC-11047 and cisplatin; CGC-11047 and 5-flurouracil / leucovorin; CGC-11047 and sunitinib
Intervention description: 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).; 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).; 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Leucovorin; Bevacizumab; Sunitinib; Gemcitabine; Docetaxel; Erlotinib Hydrochloride
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; advanced cancer; solid tumors; lymphoma; CGC-11047

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.
    

Eligibility 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.