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A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC.

Phase 1
18 Years
Open (Enrolling)
Solid Tumor, Non-small-cell Lung Cancer, Lung Cancer

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Trial Information

A Phase I Open-Label, Ascending Dose Cohort Study of Gemcitabine Elaidate and Cisplatin in Patients With Advanced Solid Tumors Followed by an Expanded Cohort of Patients With Stage IIIb/IV NSCLC.

The chemotherapy doublet of cisplatin and gemcitabine is an effective regimen for solid
tumors including NSCLC. Entry of gemcitabine into tumor cells has been shown to be
dependent on specific membrane transporter proteins, particularly human equilibrative
nucleoside transporter 1 (hENT1). Patients with low tumor hENT-1 expression may respond
poorly to gemcitabine-containing chemotherapy. Gemcitabine elaidate (CO-1.01) is a fatty
acid derivative of gemcitabine, and can enter cells in the absence of hENT1. CO-1.01
therefore, may overcome hENT1-mediated resistance to gemcitabine.

CO-1.01 is currently being evaluated as a single agent in a pivotal randomized trial in 360
patients with metastatic pancreatic adenocarcinoma. The appropriate dose of CO-1.01 when
given as part of combination therapy with a platinum agent such as cisplatin is not yet
known. The objectives of this study are to:

- determine the maximum tolerated dose (MTD) of CO-1.01 when combined with a fixed dose
of cisplatin in patients with solid tumors

- select a recommended dose (RD) for dose expansion in patients with Stage IIIb/IV NSCLC

- explore clinical activity of CO-1.01 in patients with Stage IIIb/IV NSCLC

Inclusion Criteria:

- Understand and sign institutional review board/independent ethics committee-approved
informed consent form (ICF) prior to any study-specific evaluation

- Life expectancy of at least 3 months

- ECOG performance status of 0 to 1

- ≥ 18 years at the time ICF is signed

- Adequate hematological and biological function

- Histologically or cytologically confirmed solid tumor malignancy (Part 1 only)

- Histologically or cytologically confirmed stage IIIb/IV NSCLC (Part 2 only)

Exclusion Criteria:

- Symptomatic central nervous system metastases

- Concomitant treatment with prohibited medications, e.g. other chemotherapy,
radiation, hormonal treatment (excepting corticosteroids), or immunotherapy ≤ 14 days
prior to CO-1.01 treatment

- Treatment with a previous regimen of CO-1.01

- Participation in another therapeutic clinical study within 14 days of enrollment or
during this clinical study

- Surgical procedures ≤ 14 days prior to CO-1.01 administration

- History of allergy to gemcitabine, gemcitabine elaidate or eggs

- Known allergic/hypersensitivity reaction to cisplatin, other platinum agent, or
platinum containing compounds

- Peripheral neuropathy ≥ Grade 1

- Females who are pregnant or breastfeeding

- Refusal to use adequate contraception for fertile patients

- Presence of any serious or unstable concomitant systemic disorder incompatible with
the clinical study

- Any other reason the investigator considers the patient should not participate in the

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities (DLT)(Part 1)

Outcome Time Frame:

From time taking first dose of CO-1.01 (Cycle 1 Day 1) through last day of Cycle 1 (Cycle 1 Day 21), an expected average of 6 weeks.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2012

Completion Date:

August 2013

Related Keywords:

  • Solid Tumor
  • Non-Small-Cell Lung Cancer
  • Lung Cancer
  • CO-1.01
  • CO-101
  • gemcitabine elaidate
  • hENT1
  • nucleoside equilibrative transporter
  • solid tumor
  • non-small-cell lung cancer
  • lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms



Florida Cancer Specialists Fort Myers, Florida  33901
Tennessee Oncology Nashville, Tennessee  37203