SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial
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ClinicalTrials.gov Identifier: NCT00418938 |
Recruitment Status :
Completed
First Posted : January 5, 2007
Results First Posted : March 28, 2014
Last Update Posted : October 17, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer Colon Cancer Colorectal Cancer Metastatic Cancer Rectal Cancer Metastatic Colorectal Cancer | Drug: Panitumumab Drug: Bevacizumab Drug: Leucovorin Drug: Irinotecan Drug: 5-Fluorouracil | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 266 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI With Either Panitumumab or Bevacizumab as Second-Line Treatment in Subjects With Metastatic Colorectal Cancer With Wild-type KRAS Tumors |
Actual Study Start Date : | November 1, 2006 |
Actual Primary Completion Date : | May 10, 2012 |
Actual Study Completion Date : | April 1, 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A
FOLFIRI + Panitumumab
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Drug: Panitumumab
6mg/kg IV Drug: Leucovorin 400mg/m^2 IV (in the vein) Drug: Irinotecan 180mg/m^2 IV (in the vein) Drug: 5-Fluorouracil 400mg/m^2 bolus IV (in the vein) over 2-4 min, followed by 2400mg/m^2 continuous IV over 46 hours for the first 2 cycles, increased to 3000mg/m^2 thereafter if no significant side effects |
Experimental: Arm B
FOLFIRI + Bevacizumab
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Drug: Bevacizumab
Either 5mg/kg OR 10mg/kg IV Drug: Leucovorin 400mg/m^2 IV (in the vein) Drug: Irinotecan 180mg/m^2 IV (in the vein) Drug: 5-Fluorouracil 400mg/m^2 bolus IV (in the vein) over 2-4 min, followed by 2400mg/m^2 continuous IV over 46 hours for the first 2 cycles, increased to 3000mg/m^2 thereafter if no significant side effects |
- Progression-free Survival (PFS) [ Time Frame: From randomization up to 65 months. ]Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).
- Overall Survival [ Time Frame: From randomization up to 65 months. ]Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.
- Objective Response Rate [ Time Frame: From randomization up to 65 months. ]Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.
- Time to Response [ Time Frame: From randomization up to 65 months. ]Time to response is defined as time from the date of randomization to the date of first confirmed objective response
- Time to Progression [ Time Frame: From randomization up to 65 months. ]Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).
- Disease Control [ Time Frame: From randomization up to 65 months. ]Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.
- Duration of Response [ Time Frame: From randomization up to 65 months. ]Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Diagnosis of metastatic adenocarcinoma of the colon or rectum that cannot, in the opinion of the investigator, be cured by surgical resection at the time of randomization
- Wild-type KRAS expressing mCRC from the primary tumor or metastasis.
- Failure of prior first-line oxaliplatin-based chemotherapy with bevacizumab (at least four therapeutic doses of oxaliplatin-based chemotherapy and bevacizumab) for mCRC.
- At least one uni-dimensionally measurable lesion per modified RECIST criteria.
- Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Man or woman 18 years of age or older
- Hematology, chemistry, coagution, metabolic functions within normal or protocol-defined limits
Exclusion Criteria
- Previous irinotecan, anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) or vaccine for the treatment of mCRC
- Radiotherapy ≤ 14 days before randomization
- Evidence of central nervous system (CNS) metastases
- Unresolved toxicities from prior anti-cancer therapy that, in the opinion of the investigator, precludes subject from participation
- History of other invasive primary cancer, except:
- Curatively resected or treated non-melanomatous skin cancer
- Curatively treated cervical carcinoma in situ
- Other primary solid tumor treated curatively and no treatment administered ≤ 2 years before randomization and, in the investigator's opinion, it is unlikely that there will be a recurrence ≤ 2 years post randomization
Medications
- C hronic daily treatment (as determined by the investigator) with aspirin (> 325 mg/day) or non steroidal anti inflammatory agents known to inhibit platelet function
- Infection requiring a course of systemic anti-infectives that was completed ≤ 14 days before randomization (exception can be made at the judgment of the investigator for oral treatment of an uncomplicated urinary tract infection [UTI])
- Subjects concurrently receiving any investigational agent or therapy ≤ 30 days before randomization
General:
- Significant cardiovascular risk as defined by the protocol
- History of peripheral arterial ischemia ≤ 24 weeks before randomization (subjects with brief, reversible, exercise-induced claudication are eligible)
- History of visceral arterial ischemia ≤ 24 weeks before randomization
- Significant bleeding risk:
- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days before randomization
- Anticipation of need for major surgical procedures during the course of the study
- C ore biopsy or other minor procedure, excluding placement of a vascular access device ≤ 7 days before randomization
- A ny significant bleeding that is not related to the primary colon tumor ≤ 24 weeks before randomization
- P re-existing bleeding diathesis or coagulopathy with the exception of well-controlled chronic anticoagulation therapy
- Serious or non-healing wounds, skin ulcers, or unhealed bone fractures
- Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 28 days before randomization
- History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest x-ray (CXR) or computed tomography (CT) scan
- Clinically significant ascites
- Subjects known to be human immunodeficiency virus (HIV) positive or known to have chronic or active hepatitis B or C infection
- Men and women of childbearing potential (women who are post-menopausal < 52 weeks, not surgically sterilized, or not abstinent) who do not consent to use adequate contraception (according to institutional standard of care) during the course of the study and after the last date of receiving second-line treatment (24 weeks for women, 4 weeks for men)
- Women who test positive for serum or urine pregnancy test ≤ 72 hours before randomization or are breast-feeding
- Subjects allergic to any component that is part of the treatment regimen
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): NCT00418938
Study Director: | MD | Amgen |
Publications:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00418938 |
Other Study ID Numbers: |
20060141 |
First Posted: | January 5, 2007 Key Record Dates |
Results First Posted: | March 28, 2014 |
Last Update Posted: | October 17, 2018 |
Last Verified: | September 2018 |
EGFR FOLFIRI 2nd Line Therapy 2nd Line mCRC Therapy |
mCRC Irinotecan panitumumab bevacizumab |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Bevacizumab Panitumumab Fluorouracil |
Irinotecan Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Topoisomerase I Inhibitors Topoisomerase Inhibitors |