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CompletedNCT00183872Updated Feb 19, 2018Results posted

Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

A Phase 2 interventional study of irinotecan, docetaxel in Gastric Cancer and Esophageal Neoplasms, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by University of Southern California · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2005, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after receiving treatment with the drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However, the FDA has authorized the use of irinotecan and docetaxel in this study. This study will evaluate the effects of these drugs on participant's tumors. The side effects of the combination of irinotecan and docetaxel will also be evaluated. This study will also measure the levels of certain substances in participant's tumors. These substances, called genes (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The researchers want to see if these substances can predict response to the study drugs.

02

Conditions studied

  • Gastric Cancer
  • Esophageal Neoplasms

Keywords

  • Gastroesophageal cancer
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have clinically documented unresectable or metastatic gastric cancer or gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with tumor.
  • Patients must have received one prior chemotherapeutic regimen for metastatic or unresectable disease. Patients may not have received prior therapy with irinotecan or a taxane.
  • Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
  • Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
  • Patients must have measurable disease by clinical exam or radiologic studies, that is at least one lesion measurable in at least one dimension, measuring 10 mm or more on a spiral CT scan, or at least 20 mm by an exam or a non-spiral scan. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
  • Patients must have a Zubrod performance status of 0-2.
  • Patients must have a predicted life expectancy of at least 12 weeks.

  • Patients must have:

    • a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/mm3,
    • a hemoglobin level of greater than or equal to 9.0 gm/dl, and
    • a platelet count of >100,000/mm3.
  • Patients must have adequate renal function as documented by a calculated creatinine clearance > 60.
  • Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor.
  • No major surgery within 1 month of starting study drug.
  • Women of childbearing potential must have a negative pregnancy test.
  • Peripheral neuropathy: must be \< grade 1

Exclusion criteria

Exclusion Criteria:

  • Patients may not have a history of an allergy to irinotecan.
  • Patients with any active or uncontrolled infection, including known HIV infection.
  • Patients with psychiatric disorders that would interfere with consent or follow-up.
  • Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
  • Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on treatment and for at least 3 months thereafter.
  • Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
  • Patients with any other severe concurrent disease, which in the judgment of the investigator would make the patient inappropriate for entry into this study.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Arm 1 - Irinotecan and Docetaxel

    Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days

    Drug: irinotecan, docetaxel

Interventions

  • Drugirinotecan, docetaxel

    docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.

06

What researchers measure

Primary outcomes

  1. Objective Response (Complete, Partial, Stable and Progression)

    Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.

    Time frame: every 2 cycles

Secondary outcomes

  1. Progression Free Survival

    Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause. If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.

    Time frame: every 2 cycles

07

Results

Posted Feb 19, 2018

Participant flow

Participants were recruited at the University of Southern California cancer center facilities between April 14, 2005 and January 11, 2012.

Participant flow — Overall Study
MilestoneArm 1 - Irinotecan and Docetaxel
Started40
Completed24
Not completed16
Withdrew: Death3
Withdrew: Adverse event9
Withdrew: Withdrawal by subject2
Withdrew: Drug delayed more than 28 days2

Outcome measures

PrimaryObjective Response (Complete, Partial, Stable and Progression)

Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.

Time frame:
every 2 cycles
Reported as:
Number · participants
Objective Response (Complete, Partial, Stable and Progression)
participantsArm 1 - Irinotecan and Docetaxel
CR0
PR7
SD22
PD9
SecondaryProgression Free Survival

Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause. If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.

Time frame:
every 2 cycles
Reported as:
Median · Months
Progression Free Survival
MonthsArm 1 - Irinotecan and Docetaxel
Progression Free Survival4.1 (2.9 to 6)

Adverse events

Collected over Up to 30 days after the last dose of study drug is given. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1 - Irinotecan and Docetaxel3/40 (7.5%)29/40 (72.5%)38/40 (95%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventArm 1 - Irinotecan and Docetaxel
Pain (Abdomen NOS)Gastrointestinal disorders21/40
Pain (Back)Musculoskeletal and connective tissue disorders9/40
Fatigue (asthenia, lethargy, malaise)General disorders8/40
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders6/40
Neutrophils/granulocytes (ANC/AGC)Investigations5/40
AnorexiaGastrointestinal disorders5/40
VomitingGastrointestinal disorders5/40
Leukocytes (total WBC)Investigations4/40
DiarrheaGastrointestinal disorders4/40
Pain (Head/headache)Nervous system disorders4/40
Most frequent other events
Showing 10 of 46
Most frequent other events
EventArm 1 - Irinotecan and Docetaxel
HemoglobinBlood and lymphatic system disorders36/40
Fatigue (asthenia, lethargy, malaise)General disorders27/40
Hair loss/alopecia (scalp or body)Skin and subcutaneous tissue disorders27/40
AnorexiaGastrointestinal disorders24/40
NeuropathyNervous system disorders24/40
DiarrheaGastrointestinal disorders22/40
NauseaGastrointestinal disorders22/40
Alkaline PhosphataseInvestigations21/40
AST, SGOT (serum glutamic oxaloacetic transaminase)Investigations16/40
ALT, SGPT (serum glutamic pyruvic transaminase)Investigations15/40

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm 1 - Irinotecan and Docetaxel
<=18 years0
Between 18 and 65 years29
>=65 years11
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1 - Irinotecan and Docetaxel
Female11
Male29
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm 1 - Irinotecan and Docetaxel
Hispanic or Latino15
Not Hispanic or Latino25
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm 1 - Irinotecan and Docetaxel
American Indian or Alaska Native0
Asian12
Native Hawaiian or Other Pacific Islander0
Black or African American0
White14
More than one race0
Unknown or Not Reported14
Region of Enrollment
Region of Enrollment(participants)Arm 1 - Irinotecan and Docetaxel
United States40
08

Study locations

1 site
  • University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00183872
Lead sponsor
University of Southern California
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Apr 14, 2005
Primary completion
Oct 20, 2014
Completion
Oct 20, 2015
Results posted
Feb 19, 2018
Last update
Feb 19, 2018

Study contacts

Syma Iqbal, M.D.
principal investigator · University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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