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Gemcitabine in Combination With Pemetrexed Long Term Infusion in the Treatment of Pretreated Metastatic Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT01909830
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Brief Summary:

Study Design:

Multicenter, non randomized, open label phase II study designed to evaluate the efficacy and safety of Gemcitabine/Pemetrexed combination.

Enrollment period: 18 months. Treatment period: maximum for 24 weeks for each patient (12 cycles lasting 2 weeks).

Total duration of the study: 24 months.

Number of Subjects:

Approximately 38 subjects will be enrolled on study:

- First stage:12 patients enrolled

If 1 or 0 responses were observed, the trial had to be terminated:

- Second stage: an additional of 23 patients were to be enrolled. If 5 or less responses were observed in 35 patients, the combination would not be considered worthy of further study, while if 6 or more responses were observed, the combination would be considered sufficiently active to warrant further testing. Taking into account an invalidity rate of 5%, 38 patients will be needed for this step.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Arm A : Gemcitabine + Pemetrexed Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate Activity and Toxicity of Gemcitabine in Combination With Pemetrexed Long Term Infusion in the Treatment of Pretreated Metastatic Colorectal Cancer Patients
Study Start Date : July 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A : Gemcitabine + Pemetrexed

Arm A : Gemcitabine: 1000 mg/m2 by intravenous infusion over an exact period of 30' (preferably by a pump to guarantee a constant speed of infusion) on day 3 of each cycle repeated every 14 days.

Pemetrexed: 150 mg/m2 by intravenous continuous infusion over an exact period of 8h on day 1 of each cycle repeated every 14 days.

Drug: Arm A : Gemcitabine + Pemetrexed

Gemcitabine: 1000 mg/m2 by intravenous infusion over an exact period of 30' (preferably by a pump to guarantee a constant speed of infusion) on day 3 of each cycle repeated every 14 days.

Pemetrexed: 150 mg/m2 by intravenous continuous infusion over an exact period of 8h on day 1 of each cycle repeated every 14 days.

Other Names:
  • Gemcitabine
  • Pemetrexed




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 2 years ]
    Determination of the objective response rate (ORR: CR (complete response) +PR (partial response) +SD (stable disease)) of treated patients according to RECIST criteria


Secondary Outcome Measures :
  1. safety profile of study treatment [ Time Frame: 2 years ]
    Assessment of safety profile of study drug combination in patients treated: report of Adverse Events according to the The NCI's Common Toxicity Criteria version 4.0

  2. Time to Progression (TTP) [ Time Frame: 2 years ]
    Determination of Time to Progression (TTP) of treated patients

  3. Overall Survival (OS) [ Time Frame: 2 years ]
    Determination of Overall Survival (OS) of treated patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologic or cytologic confirmed diagnosis of colorectal carcinoma with metastatic (STAGE IV) disease.
  2. Measurable disease according to RECIST criteria
  3. Prior chemotherapy for metastatic disease is required; prior regimens (in adjuvant oral advanced stage setting) must include 5fluorouracile, Oxaliplatin and Irinotecan if not contraindicated.
  4. At least a 4-week interval between the last dose of chemotherapy and study registration.
  5. Recovery from all prior treatment-related toxicities to CTC <= grade 1 (except alopecia)
  6. Male or female, aged >= 18 years
  7. Life expectancy of greater than 12 weeks.
  8. ECOG performance status <= 2
  9. Patients must have normal organ and marrow function as defined below:

    • leukocytes >=3,000/microL
    • absolute neutrophil count >=1,500/microL
    • hemoglobin >= 9 g/dl
    • platelets >=100,000/microL
    • serum total bilirubin <= 1.5 X institutional upper limit of normal
    • AST(SGOT)/ALT(SGPT) <= 2.5 X institutional upper limit of normal (<= 5 times the upper institutional limits of normal if hepatic metastases are present)
    • serum creatinine <= 1.5 times the institutional upper limits of normal
    • Creatinine Clearance > 45 ml/min
  10. The effects of Gemcitabine and Pemetrexed on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception (hormonal or barrier method of birth control; abstinence) during the study and for 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  11. Participant is willing and able to give informed consent for participation in the study. Voluntary signed and dated written informed consent form in accordance with regulatory and institutional guidelines obtained before the performance of any protocol-related procedures not part of normal patient care.

Exclusion Criteria:

  1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  2. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  3. Previous treatment with Gemcitabine or Pemetrexed.
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gemcitabine and/or Pemetrexed or other agents used in the study
  5. Patients with active brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  6. Past or current history of neoplasm other than colorectal carcinoma with a disease-free interval of less than 5 years, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix.
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before, the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin.
  9. HIV-positivity, whether or not symptomatic.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909830


Locations
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Italy
UO Oncologia Medica IRCCS IRST
Meldola (FC), FC, Italy, 47014
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
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Principal Investigator: Giovanni Luca Frassineti, MD IRST IRCCS, Meldola

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT01909830     History of Changes
Other Study ID Numbers: IRST153.03
2010-019841-25 ( EudraCT Number )
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
Colorectal Cancer Metastatic
pretreated

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors