Gemcitabine and Irinotecan in Treating Patients With Cancer of Unknown Primary

NCT00066781 | Completed Phase 2 Results

• 3 other identifiers: NCCTG-N004ENCI-2011-01592CDR0000318830
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with cancer of unknown primary origin.

Conditions

Carcinoma of Unknown Primary

Keywords

adenocarcinoma of unknown primary; newly diagnosed carcinoma of unknown primary; squamous cell carcinoma of unknown primary; undifferentiated carcinoma of unknown primary

Outcome Measures

Primary Outcomes (1)

• Confirmed Response Rate (Partial or Complete Response for 2 Consecutive Evaluations at Least 4 Weeks Apart) as Measured by RECIST Criteria

  The primary endpoint is confirmed response rate. If measurable disease is present, a confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. All registered patients meeting the eligibility criteria that have signed a consent form and have begun treatment will be evaluable for response.

  Up to 2 years

Secondary Outcomes (2)

• Overall Survival

  Up to 2 years

• Time to Disease Progression

  Up to 2 years

Study Arms (2)

Cohort I (closed to accrual 11/17/05)

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Irinotecan dose may be escalated or de-escalated after course 1 depending on toxicity. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

Cohort II

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: gemcitabine hydrochloride; Drug: irinotecan hydrochloride

Interventions

gemcitabine hydrochloride DRUG

Given IV

Cohort I (closed to accrual 11/17/05); Cohort II

irinotecan hydrochloride DRUG

Given IV

Cohort I (closed to accrual 11/17/05); Cohort II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed carcinoma of undetermined origin, with any of the following light microscopic diagnoses: * Adenocarcinoma * Poorly differentiated non-small cell carcinoma * Poorly differentiated squamous cell carcinoma * Primary site not revealed by the following diagnostic tests: * Complete history and physical * Complete blood count and chemistries * Chest x-ray and/or CT scan * Abdominal CT scan * Directed evaluation of symptomatic areas * Mammogram in women * Colonoscopy in patients with liver metastases to exclude a colon primary * Hematoxylin and eosin (H\&E) staining OR immunostaining if H\&E results are unclear, including all of the following: * Keratin or epithelial membrane antigen * S-100 or HMB45 * LCA (CD45) * Chromogranin or synaptophysin * Thyroid transcription factor 1 * Measurable disease * Patients with any of the following conditions are not eligible: * Neuroendocrine tumors * Women with axillary node involvement only * Women with adenocarcinoma of the peritoneum * Carcinoma involving only 1 site, with resectable tumor at that site * Squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes * Men with poorly differentiated mediastinal or retroperitoneal tumor with stains suggestive of germ cell origin or serum tumor markers (AFP/HCG) * Men with prominent blastic bony metastases or markedly elevated prostate-specific antigen, suggesting prostate origin * Must be willing to provide blood and tissue samples * No brain or meningeal involvement PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin must meet 1 of the following criteria: * Less than or equal to upper limit of normal (ULN) and no UGT1A1 genotyping is required * Greater than ULN but less than 2 times ULN and UGT1A1 for 6/7 genotype or 7/7 genotype patients * Alkaline phosphatase no greater than 3 times ULN * AST no greater than 3 times ULN (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 2.0 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other invasive malignancy within the past 5 years * No other severe concurrent disease that would make the patient inappropriate for the study in the judgment of the investigator * No uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent biologic agents * No concurrent filgrastim (G-CSF) Chemotherapy * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to more than 25% of the bone marrow * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Cancer Resource Center - Lincoln

Lincoln, Nebraska, 68510, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Related Publications (2)

• Holtan SG, Foster NR, Erlichman CE, et al.: Gemcitabine (G) and irinotecan (CPT-11) as first-line therapy for carcinoma (ca) of unknown primary (CUP): An NCCTG phase II trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-13525, 2008.

  RESULT

• Holtan SG, Steen PD, Foster NR, Erlichman C, Medeiros F, Ames MM, Safgren SL, Graham DL, Behrens RJ, Goetz MP. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial. PLoS One. 2012;7(7):e39285. doi: 10.1371/journal.pone.0039285. Epub 2012 Jul 17.

  PMID: 22815703 DERIVED

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

Gemcitabine; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Results Point of Contact

• Title: Matthew Goetz, M.D.
• Organization: Mayo Clinic

goetz.matthew@mayo.edu

(507) 284-2511

Study Officials

• Matthew P. Goetz, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: February 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: March 1, 2009
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (4)