Irinotecan and Cisplatin for High Grade Neuroendocrine Carcinoma of the Gastrointestinal Tract

NCT00353015 | Completed Phase 2

• 1 other identifier: ID02-523
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: 1\. Assess the clinical activity defined by response rate of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract. Secondary Objective: 1\. To assess the safety profile of irinotecan and cisplatin in untreated patients with metastatic or unresectable high grade neuroendocrine carcinoma of the gastrointestinal tract.

Conditions

Gastrointestinal Cancer; Carcinoma, Neuroendocrine

Keywords

Gastrointestinal cancer; high grade gastrointestinal neuroendocrine carcinoma; High grade neuroendocrine carcinoma of unknown primary site; Cisplatin; Platinol-AQ; Platinol; CDDP; CPT-11; Irinotecan

Outcome Measures

Primary Outcomes (1)

• Participant Response Rate of Irinotecan and Cisplatin

  Clinical activity defined by number of participants with Complete Response (CR) and Partial Response (PR) divided by total number of particpants using Response Evaluation Criteria in Solid Tumors (RECIST) where changes in tumor measurements confirmed by repeat assessments no less than 4 weeks after criteria for CR and PR responses first met.

  Every 3 weeks

Study Arms (1)

Irinotecan plus Cisplatin

EXPERIMENTAL

Irinotecan 65 mg/m2 and Cisplatin 25 mg/m2 intravenous (IV) days 1, 8 of a 21-day cycle

Drug: Cisplatin; Drug: Irinotecan

Interventions

Cisplatin DRUG

Cisplatin 25 mg/m2 IV days 1, 8 of a 21-day cycle

Also known as: Platinol-AQ, Platinol, CDDP

Irinotecan plus Cisplatin

Irinotecan DRUG

Irinotecan 65 mg/m2 IV days 1, 8 of a 21-day cycle

Also known as: CPT-11

Irinotecan plus Cisplatin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of high grade (poorly differentiated, small cell) gastrointestinal neuroendocrine carcinoma.
• High grade neuroendocrine carcinoma of unknown primary site (if a pulmonary primary has been excluded).
• Metastatic or unresectable disease.
• Measurable disease.
• Informed consent.
• Zubrod performance status of 0 or 1.
• Adequate bone marrow function (defined as absolute neutrophil count \[ANC\] \>= 1500, platelet count \[PLT\] \>= 100,000 and a hemoglobin \[Hgb\] \>= 10).
• Adequate hepatic function with a bilirubin of \<= 2.0 mg/dl, and aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \<= 2.5 times the upper limits of normal, unless caused by liver metastasis. If caused by metastasis, then should be SGPT and SGOT \<= 5 times the upper limits of normal.
• Adequate renal function defined as serum creatinine \<= 1.5 mg/dl.
• Fertile patients and their partners must practice appropriate contraceptive methods while on study.
• Recovered from recent surgery. One week must have elapsed from the time of a minor surgery and 3 weeks from major surgery.

You may not qualify if:

• Patients with prior systemic chemotherapy are ineligible.
• Other concurrent chemotherapy, immunotherapy, or radiotherapy.
• Patients with brain metastases are not eligible. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible.
• Patients with New York Heart Association (NYHA) Class III or IV heart disease are not eligible as well as those patients with history of angina, myocardial infarction, or congestive heart failure within six months.
• Pregnant or lactating women. All women of child bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
• Patients with serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, are ineligible.
• Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol are ineligible.
• Patients with serum calcium \> 12 mg/dl or symptomatic hypercalcemia under treatment are ineligible.
• Patients with osseous metastasis as only site of disease.
• Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
• Patients with known Gilbert's syndrome are ineligible.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pharmacia: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Carcinoma, Neuroendocrine

Interventions

Cisplatin; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• James C. Yao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 17, 2006
• Study Start: March 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: July 1, 2009
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)