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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Progen Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00705874
First received: June 23, 2008
Last updated: January 22, 2012
Last verified: January 2012

June 23, 2008
January 22, 2012
May 2006
August 2011   (final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) [ Time Frame: End of Study ] [ Designated as safety issue: No ]

The MTD was defined as the dose below which one-third of at least 6 patients (2/6) experienced a dose limiting toxicity (DLT).

DLTs had to occur during cycle 1 of treatment and had to be considered related to PG-11047:

  1. Any nonhematologic toxicity > Grade 3 lasting > 3 days
  2. Grade 4 thrombocytopenia
  3. Grade 4 Anemia on the next scheduled dosing day
  4. Grade 4 Neutropenia (lasting > than 5 days
  5. Any febrile neutropenia (Grade 3 or 4))
  6. Inability to receive all scheduled doses of PG-11047 during the first dosing cycle due to drug related toxicity
Maximum Tolerated Dose (MTD) [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00705874 on ClinicalTrials.gov Archive Site
  • Drug Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Dose Limiting Toxicity, Safety and Pharmacokinetics 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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
  • 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).
    Other Name: Gemzar
  • 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).
    Other Name: Taxotere
  • 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.
    Other Name: Avastin
  • 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.
    Other Name: Tarceva
  • 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.
    Other Names:
    • 5-FU
    • Florouracil
    • Efudix
  • 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.
    Other Name: Sutent
  • Experimental: 1
    CGC-11047 in combination with Gemcitabine
    Intervention: Drug: CGC-11047 and gemcitabine
  • Experimental: 2
    CGC-11047 in combination with Docetaxel
    Intervention: Drug: CGC-11047 and docetaxel
  • Experimental: 3
    CGC-11047 in combination with Bevacizumab
    Intervention: Drug: CGC-11047 and bevacizumab
  • Experimental: 4
    CGC-11047 in combination with Erlotinib
    Intervention: Drug: CGC-11047 and 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.
    Intervention: Drug: CGC-11047 and cisplatin
  • Experimental: 6
    CGC-11047 in combination with 5-Flurouracil / Leucovorin
    Intervention: Drug: CGC-11047 and 5-flurouracil / leucovorin
  • Experimental: 7
    CGC-11047 in combination with Sunitinib
    Intervention: Drug: CGC-11047 and sunitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
September 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00705874
47-01-002
No
Progen Pharmaceuticals
Progen Pharmaceuticals
Not Provided
Principal Investigator: Joe Stephenson, MD Cancer Centres of the Carolinas, Greenville, SC 29605
Progen Pharmaceuticals
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP