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

PHASE1CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

August 31, 2011

Study Completion Date

September 30, 2011

Conditions
Cancer
Interventions
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).

DRUG

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).

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (12)

12206

New York Oncology Hematology PC, Albany

23502

Virginia Oncology Associates, Norfolk

29605

Cancer Centres of the Carolinas, Greenville

34761

Cancer Centres of Florida, Ocoee

45409

Dayton Oncology and Hematology, PA, Kettering

46219

Central Indiana Cancer Centres, Indianapolis

75246

Texas Oncology, PA, Dallas

75702

Tyler Cancer Centre, Tyler

89169

Comprehensive Cancer Centres of Nevada, Las Vegas

98684

Northwest Cancer Specialists - Vancouver Cancer Centre, Vancouver

98902

North Star Lodge Cancer Centre, Yakima

Unknown

Rocky Mountain Cancer Centre, Denver

Sponsors
All Listed Sponsors
lead

Progen Pharmaceuticals

INDUSTRY