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Advanced Gastrointestinal MalignanciesPhase 1NCT00660426

Study Of Advanced Gastrointestinal Malignancies And Other Solid Tumors

A Phase 1 study testing Oxaliplatin, Gemcitabine and Capecitabine in people with Advanced Gastrointestinal Malignancies and Solid Tumors, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dose escalation of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Oxaliplatin, Gemcitabine and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 2005to Apr 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological Diagnosis: Patients must have a histological or cytological proven advanced gastrointestinal or other solid malignancy.
  • Measurable or Evaluable Disease: See RECIST Criteria: www.cancer.gov/dip/RECIST
  • Age: Patients must be 18 years old or older. Because no dosing or toxicity data are currently available on the use of oxaliplatin in patients <18 years of age, children are excluded from this study, but will be eligible for other pediatric Phase I single-agent trials, when available.
  • Performance Status: NCI CTC 0-2.
  • Life Expectancy: >=8 weeks.
  • Recovery from Prior Therapy: Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and must be without significant systemic illness (e.g. infection). No chemotherapy or radiotherapy may be given within 3 weeks prior to the start of protocol treatment. Patients must have received <= 2 prior chemotherapy regimes.
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  • Recovery from Intercurrent Illness: Patients must have recovered from uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
  • Hematological Status: Patients must have adequate bone marrow function which is defined as an absolute neutrophil count >= 1,500/mm³, platelet count >= 100,000/mm³ and hemoglobin >= 9 g/dl.
  • Hepatic Function: Total bilirubin must be <= institutional limit of normal (ULN). Transaminases (SGOT and/or SGPT) must be <= 4 x ULN.
  • Neurological Status: Patients must not have active CNS metastases. Patients with Grade 2 or higher peripheral neuropathy are ineligible due to the potential neurological complications of oxaliplatin therapy.
  • Renal Function: Patients must have adequate renal function defined as serum creatinine <= 2.0 mg/dl or creatinine clearance >= 60 ml/min/1.73m² for patients with creatinine levels above 2.0 mg/dl.
  • Sexually Active Patients: For all sexually active patients, the use of adequate barrier contraception (hormonal or barrier method of birth control) will be required during therapy, prior to study entry and for the duration of study participation. Non-pregnant status will be determined in all women of childbearing potential. Pregnant and nursing women patients are not eligible.
  • HIV-Positive Patients: Patients receiving anti-retroviral therapy (HAART) for HIV infection are excluded from the study because of possible pharmacokinetic interactions. Appropriate protocols will be offered to patients receiving HAART therapy, when indicated.
  • No known hypersensitivity to oxaliplatin, gemcitabine or capecitabine
  • No pre-existing clinically significant cardiac, hepatic or renal disease.
  • Informed Consent: After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
  • Inclusion of Women and Minorities: Entry to this study is open to both men and women and to all racial and ethnic groups.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase I Study Of Oxaliplatin, Gemcitabine And Capecitabine In Advanced Gastrointestinal Malignancies And Other Solid Tumors

Dose escalation of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

Read the detailed description

To define the maximum tolerated dose of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

Keywords
cancer, gastrointestinal, tumor
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00660426
Study groupRoleWhat they receive
Dose Level 1 (starting level)ExperimentalOxaliplatin 85 mg/m2 IV on days 1 and 15. Gemcitabine 800 mg/m2 IV on days 1 and 15. Capecitabine 600 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet. Each cycle is 28 days.
Receives: Drug: Oxaliplatin; Drug: Gemcitabine; Drug: Capecitabine
Dose Level 2ExperimentalOxaliplatin 100 mg/m2 IV on days 1 and 15. Gemcitabine 800 mg/m2 IV on days 1 and 15. Capecitabine 600 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet. Each cycle is 28 days.
Receives: Drug: Oxaliplatin; Drug: Gemcitabine; Drug: Capecitabine
Dose Level 3ExperimentalOxaliplatin 100 mg/m2 IV on days 1 and 15. Gemcitabine 800 mg/m2 IV on days 1 and 15. Capecitabine 800 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet. Each cycle is 28 days.
Receives: Drug: Oxaliplatin; Drug: Gemcitabine; Drug: Capecitabine
Dose Level 4ExperimentalOxaliplatin 100 mg/m2 IV on days 1 and 15. Gemcitabine 1000 mg/m2 IV on days 1 and 15. Capecitabine 800 mg/m2 BID orally on days 1-7 and days 15-21 rounded off to the nearest 150 mg or 500 mg tablet. Each cycle is 28 days.
Receives: Drug: Oxaliplatin; Drug: Gemcitabine; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To define the maximum tolerated dose of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

    Measured: At the end of dose escalation (approximately 18 months)

Secondary outcomes (4)

  1. To determine the dose-limiting toxicity of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

    Completion of 1st cycle

    Measured: Approximately 28 days into treatment

  2. To evaluate the incidence and severity of other toxicities of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors.

    Measured: 30 days after the end of treatment

  3. To perform a structured neurological assessment and questionnaire and report neurological toxicities of oxaliplatin when used with this combination.

    Measured: 30 days after end of treatment

  4. To perform correlative pharmacogenomic and pharmacokinetic tests for this novel regimen.

    PKs - expanded cohort only

    Measured: Day 1, 7, 15, and 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2008 (estimated)
  2. Study startMar 2005
  3. Primary completionOct 2006
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00660426
Sponsor's protocol ID
04-1213
Status last verified
Apr 2013
First submitted
11 Apr 2008
Last updated
23 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oxaliplatin, Gemcitabine and Capecitabine in people with Advanced Gastrointestinal Malignancies and Solid Tumors, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To define the maximum tolerated dose of oxaliplatin, gemcitabine and capecitabine in the treatment of patients with advanced gastrointestinal malignancies and other solid tumors. (time frame: At the end of dose escalation (approximately 18 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00660426.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.

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