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

Conditions

• Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CGC-11047 and gemcitabine — DRUG
  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).
• CGC-11047 and docetaxel — DRUG
  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).
• CGC-11047 and bevacizumab — DRUG
  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.
• CGC-11047 and erlotinib — DRUG
  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.
• CGC-11047 and cisplatin — DRUG
  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.
• CGC-11047 and 5-flurouracil / leucovorin — DRUG
  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.
• CGC-11047 and sunitinib — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jun 26, 2008

Start date

May 31, 2006

Status verified

Jun 2016

Primary completion

Aug 31, 2011

Completion

Sep 30, 2011

Study Design

Enrollment

172 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
  CGC-11047 in combination with Gemcitabine
• Experimental: 2
  CGC-11047 in combination with Docetaxel
• Experimental: 3
  CGC-11047 in combination with Bevacizumab
• Experimental: 4
  CGC-11047 in combination with Erlotinib
• Experimental: 5
  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.
• Experimental: 6
  CGC-11047 in combination with 5-Flurouracil / Leucovorin
• Experimental: 7
  CGC-11047 in combination with Sunitinib

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: End of Study ]

Locations (12)

Find similar trials in Denver, CO

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