Trial record 1 of 1 for:
NCT01061515
Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab for Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer
This study is currently recruiting participants.
Verified May 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01061515
First received: February 1, 2010
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
This study is to test escalating doses of intraperitoneal (IP) oxaliplatin in conjunction with systemic bevacizumab and capecitabine in patients with Peritoneal Carcinomatosis (PC) from either appendiceal or colorectal adenocarcinoma that have been adequately cytoreduced and have undergone a peritoneal scan demonstrating patency of at least one of the intraperitoneal ports that were placed at the time of debulking.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma |
Drug: Intraperitoneal Oxaliplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-Escalation Trial of Biweekly Intraperitoneal Oxaliplatin With Systemic Capecitabine and Bevacizumab Following Cytoreduction in Patients With Peritoneal Carcinomatosis From Appendiceal or Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after surgical debulking and peritoneal scan documenting functional of intraperitoneal ports in patients with peritoneal carcinomatosis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Assess the safety and tolerability of IP oxaliplatin and intravenous (i.v.) bevacizumab and oral capecitabine after surgical debulking and functional intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2019 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intraperitoneal Oxaliplatin 25 mg/m²
Intraperitoneal Oxaliplatin
|
Drug: Intraperitoneal Oxaliplatin
Intraperitoneal Oxaliplatin 25 mg/m² on day 1 of cycle, Bevacizumab-Continuous Intravenous Infusion (CIVI) 5 mg/kg on day 1 of each cycle, Capecitabine- 850 mg/m² PO (by mouth) BID (twice a day) days 1-7 each cycle, Day 8 thru 14 rest
Other Names:
|
|
Experimental: Intraperitoneal Oxaliplatin 50 mg/m²
Intraperitoneal Oxaliplatin
|
Drug: Intraperitoneal Oxaliplatin
Intraperitoneal Oxaliplatin 50 mg/m² on day 1 of cycle, Bevacizumab-CIVI 5 mg/kg on day 1 of each cycle, Capecitabine- 850 mg/m² PO BID days 1-7 each cycle, Day 8 thru 14 rest
Other Names:
|
|
Experimental: Intraperitoneal Oxaliplatin 65 mg/m²
Intraperitoneal Oxaliplatin
|
Drug: Intraperitoneal Oxaliplatin
Intraperitoneal Oxaliplatin 65 mg/m² on day 1 of cycle, Bevacizumab-CIVI 5 mg/kg on day 1 of each cycle, Capecitabine- 850 mg/m² PO BID days 1-7 each cycle, Day 8 thru 14 rest
Other Names:
|
|
Experimental: Intraperitoneal Oxaliplatin 85 mg/m²
Intraperitoneal Oxaliplatin
|
Drug: Intraperitoneal Oxaliplatin
Intraperitoneal Oxaliplatin 85 mg/m² on day 1 of cycle, Bevacizumab-CIVI 5 mg/kg on day 1 of each cycle, Capecitabine- 850 mg/m² PO BID days 1-7 each cycle, Day 8 thru 14 rest
Other Names:
|
|
Experimental: Intraperitoneal Oxaliplatin 100 mg/m²
Intraperitoneal Oxaliplatin
|
Drug: Intraperitoneal Oxaliplatin
Intraperitoneal Oxaliplatin 100 mg/m² on day 1 of cycle, Bevacizumab-CIVI 5 mg/kg on day 1 of each cycle, Capecitabine- 850 mg/m² PO BID days 1-7 each cycle, Day 8 thru 14 rest
Other Names:
|
Detailed Description:
- To determine the maximum tolerated dose of IP oxaliplatin with systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function of intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.
- To assess the safety and tolerability of repeated delayed intraperitoneal chemotherapy with oxaliplatin and systemic intravenous bevacizumab and oral capecitabine after adequate surgical debulking and peritoneal scan documenting function of intraperitoneal ports in patients with peritoneal carcinomatosis of appendiceal or colorectal etiology.
- To describe the progression rate, progression-free survival and overall survival in patients treated with this regimen.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must fulfill (or have previously met) the following eligibility requirements prior to initiation of chemotherapy:
- Histological Diagnosis: Patients must have a histologically documented peritoneal carcinomatosis from either colorectal or appendiceal adenocarcinoma.
- Prior Surgical Debulking and Port Placements: Patients must have undergone debulking surgery with peritonectomy and placement of intraperitoneal ports and have been allowed at least 4 weeks to recover prior to receiving chemotherapy.
- Active port: Patients must undergo a peritoneal scan documenting at least one working intraperitoneal port prior to receiving chemotherapy.
- Patients may have received prior chemotherapy.
- Age: Patients must be ≥18 years of age. Because no dosing or toxicity data are currently available on the use of oxaliplatin in patients <18 years of age.
- Performance Status: (Eastern cooperativeOncology Group) ECOG 0-2.
- 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 arrhythmias.
- Inclusion of Women and Minorities: Entry to this study is open to both men and women and to all racial and ethnic subgroups.
- Informed Consent: All patients must be consented prior to chemotherapy. The patient should not have any serious medical of psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment.
- Hematological Status: absolute neutrophil count ≥1,500/mm³, platelet count ≥100,000/mm³, and hemoglobin ≥8 g/dl.
- Hepatic function: Total bilirubin must be <2X the institutional upper limit of normal (ULN); Transaminases (SGOT and/or SGPT) must be ≤3X the institutional upper limit of normal (ULN; Alkaline phosphatase must be ≤4X the institutional upper limit of normal (ULN)
- Renal Function: Patients must have adequate renal function prior to chemotherapy defined as serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥60 ml.min/1.73 m² for patients with creatinine levels above 2.0 mg/dl.
Exclusion Criteria:
- Pregnant or breast feeding: For all sexually active patients, the use of adequate 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.
- Prior history of hypersensitivity reactions to oxaliplatin, bevacizumab, 5-FU or capecitabine.
- Gastrointestinal ailments that may alter the absorption of oral medications (i.e. bowel obstruction, short-gut syndrome).
- Patients receiving antiretroviral therapy Highly Active Anti Retroviral Treatment (HAART) for HIV infection are excluded from the study because of possible pharmacokinetic interactions. Appropriate studies will be undertaken in patients receiving HAART therapy, when indicated.
- Patients with Grade 2 or higher peripheral neuropathy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061515
Contacts
| Contact: Benjamin Tan, M.D. | 314-362-9115 | btan@dom.wustl.edu |
Locations
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Benjamin Tan, M.D. 314-362-9115 btan@dom.wustl.edu | |
| Sub-Investigator: Matthew Mutch, M.D. | |
| Sub-Investigator: Steven Sorscher, M.D. | |
| Sub-Investigator: Craig Lockhart, M.D. | |
| Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D. | |
| Sub-Investigator: Bashar Safar, MBBS, MRCS | |
| Sub-Investigator: Caron Rigden, M.D. | |
| Sub-Investigator: Elisa H Birnbaum, M.D. | |
| Sub-Investigator: Tanya Wildes, M.D. | |
| Sub-Investigator: Rama Suresh, M.D. | |
Sponsors and Collaborators
Washington University School of Medicine
Investigators
| Principal Investigator: | Benjamin Tan, M.D. | Washington University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01061515 History of Changes |
| Other Study ID Numbers: | 10-0136 / 201107017 |
| Study First Received: | February 1, 2010 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Oxaliplatin Capecitabine Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013